Cegfila (Pegfilgrastim)
Granulocyte colony-stimulating factor (G-CSF) biosimilar for chemotherapy-induced neutropenia
Quick Facts About Cegfila
Key Takeaways About Cegfila
- Prevents chemotherapy-related infections: Cegfila stimulates neutrophil production, significantly reducing the risk of febrile neutropenia and serious infections during cancer treatment
- Convenient once-per-cycle dosing: Unlike daily G-CSF injections (filgrastim), Cegfila requires only a single 6 mg injection approximately 24 hours after each chemotherapy cycle
- EMA-approved biosimilar: Cegfila has been rigorously evaluated and approved as a biosimilar of Neulasta, meeting identical standards of quality, safety, and efficacy
- Bone pain is the most common side effect: Musculoskeletal and bone pain affect more than 1 in 10 patients, but can usually be managed with standard pain relief such as paracetamol or ibuprofen
- Timing is critical: Cegfila must not be given within 14 days before or 24 hours after cytotoxic chemotherapy administration
What Is Cegfila and What Is It Used For?
Cegfila (pegfilgrastim) is a biosimilar G-CSF medicine given as a subcutaneous injection to reduce the duration and incidence of neutropenia in adult cancer patients receiving myelosuppressive chemotherapy. It works by stimulating the bone marrow to produce more neutrophils, the white blood cells most important for fighting bacterial infections.
Cegfila contains the active substance pegfilgrastim, which belongs to a group of medicines called granulocyte colony-stimulating factors (G-CSFs). Pegfilgrastim is a long-acting form of filgrastim, produced by recombinant DNA technology in Escherichia coli bacteria and then conjugated with a polyethylene glycol (PEG) molecule. This PEGylation significantly extends the half-life of the molecule, allowing for convenient once-per-chemotherapy-cycle dosing instead of daily injections.
Chemotherapy drugs, while essential for destroying cancer cells, also damage rapidly dividing healthy cells in the bone marrow. This leads to a reduction in neutrophils – a condition known as neutropenia. When the absolute neutrophil count (ANC) falls below 0.5 × 109/L, the patient is classified as having severe neutropenia and is at substantial risk for life-threatening bacterial and fungal infections. Febrile neutropenia – neutropenia accompanied by fever – is a medical emergency that frequently requires hospitalisation, intravenous antibiotics, and may necessitate dose reductions or delays in subsequent chemotherapy cycles, potentially compromising cancer treatment outcomes.
By binding to G-CSF receptors on neutrophil precursor cells in the bone marrow, pegfilgrastim stimulates the proliferation, differentiation, and functional activation of these cells. Clinical trials have demonstrated that pegfilgrastim significantly reduces the duration of severe neutropenia, the incidence of febrile neutropenia, the need for hospitalisation, and the use of intravenous antibiotics. This allows patients to maintain their chemotherapy schedule at the planned dose intensity, which is crucial for optimal cancer treatment outcomes.
Cegfila as a biosimilar
Cegfila is a biosimilar of the reference medicine Neulasta, which was first authorised in the European Union in 2002. A biosimilar is a biological medicine that is highly similar to another biological medicine already approved (the reference product). Biosimilars are approved only after comprehensive analytical, non-clinical, and clinical studies have demonstrated that they are equivalent to the reference product in terms of quality, safety, and efficacy. The European Medicines Agency (EMA) has confirmed that Cegfila meets all the requirements for biosimilar approval.
It is important to understand that biosimilars are not the same as generic medicines. While generics are chemically identical copies of small-molecule drugs, biosimilars are highly similar but not identical to their reference biological products due to the inherent complexity of biological manufacturing processes. However, any minor differences in structure have been shown not to affect clinical performance. Biosimilar medicines play an important role in increasing access to essential biological therapies by offering more cost-effective treatment options.
Neutrophils are the most abundant type of white blood cell and form the body's first line of defence against bacterial and fungal infections. A normal neutrophil count is between 2.0 and 7.5 × 109/L. When the count drops below 1.0 × 109/L, infection risk increases significantly. Below 0.5 × 109/L (severe neutropenia), patients are at high risk of serious, potentially life-threatening infections. G-CSF medicines like Cegfila help the bone marrow recover more quickly after chemotherapy.
What Should You Know Before Taking Cegfila?
Before receiving Cegfila, inform your doctor about any allergies, kidney or liver disease, sickle cell disease, or if you are pregnant or breastfeeding. Cegfila must not be used to increase chemotherapy doses beyond established regimens. Timing of administration relative to chemotherapy is critical for both safety and efficacy.
Cegfila is a prescription medicine that should only be used under the supervision of a physician experienced in oncology or haematology. Before starting treatment, your healthcare team will evaluate your overall health, current medications, and specific chemotherapy regimen to determine whether Cegfila is appropriate for you. It is essential to provide your doctor with a complete medical history and to report any new symptoms that develop during treatment.
Contraindications
Cegfila must not be used if you have a known hypersensitivity to pegfilgrastim, filgrastim, or any of the excipients in the formulation. Patients with a history of serious allergic reactions to E. coli-derived proteins should not receive Cegfila. Allergic reactions, including anaphylaxis, have been reported with G-CSF products and can occur on initial or subsequent exposures. If a serious allergic reaction occurs, treatment should be permanently discontinued and appropriate medical treatment administered.
Warnings and Precautions
Several important precautions apply to Cegfila use. Your doctor will monitor you carefully for the following potential complications:
- Splenic rupture: Cases of splenic rupture, including fatal cases, have been reported following administration of G-CSF products. Patients experiencing left upper abdominal or shoulder tip pain should seek immediate medical attention, as this may indicate splenic enlargement or rupture
- Acute respiratory distress syndrome (ARDS): ARDS has been reported in patients receiving G-CSFs. Patients who develop fever, lung infiltrates, or respiratory distress should be evaluated for ARDS and Cegfila should be discontinued if ARDS is confirmed
- Sickle cell crises: Severe and sometimes fatal sickle cell crises have been reported in patients with sickle cell disease receiving G-CSFs. Cegfila should be used with caution in patients with sickle cell trait or sickle cell disease
- Glomerulonephritis: Glomerulonephritis has been reported in patients receiving pegfilgrastim. Cases generally resolved after dose reduction or discontinuation. Urinalysis monitoring is recommended
- Capillary leak syndrome: Capillary leak syndrome has been reported after G-CSF administration, characterised by hypotension, hypoalbuminaemia, oedema, and haemoconcentration. Patients who develop symptoms should be closely monitored and receive standard symptomatic treatment
- Leukocytosis: White blood cell counts of 100 × 109/L or greater have been observed in less than 1% of patients. No adverse effects directly attributable to this degree of leukocytosis have been reported, but regular blood count monitoring is advised
- Thrombocytopenia: Thrombocytopenia has been reported with pegfilgrastim use. Platelet counts should be monitored regularly
- Aortitis: Aortitis has been reported after G-CSF administration. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers
Pregnancy and Breastfeeding
There are limited data on the use of pegfilgrastim in pregnant women. Animal studies have shown reproductive toxicity, including increased embryo loss and reduced foetal weight at high doses. Cegfila should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus. Women of childbearing potential should use effective contraception during treatment.
It is not known whether pegfilgrastim is excreted in human breast milk. A risk to the breastfed infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Cegfila therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Cegfila must not be administered between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Administering Cegfila too close to chemotherapy can increase the sensitivity of rapidly dividing myeloid cells to the cytotoxic effects, potentially worsening rather than improving neutropenia. Always follow your oncologist's precise timing instructions.
How Does Cegfila Interact with Other Drugs?
The most critical interaction is with cytotoxic chemotherapy agents – Cegfila must not be given within 24 hours before or after chemotherapy. Lithium may enhance neutrophil production when used with Cegfila. No significant interactions have been reported with most other commonly used medicines.
Drug interactions with pegfilgrastim are relatively limited because it is a biological protein rather than a small molecule processed through hepatic cytochrome P450 enzymes. However, several important interactions must be considered. The interaction profile of Cegfila is expected to be identical to that of the reference product Neulasta, as they share the same active substance.
Clinical studies have not formally evaluated the interaction potential of pegfilgrastim with a wide range of concomitant medications. However, post-marketing experience and the known pharmacology of G-CSF allow the identification of several relevant interactions. It is always important to inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins.
| Interacting Drug | Type | Effect | Clinical Advice |
|---|---|---|---|
| Cytotoxic chemotherapy | Major | Increased myelosuppression if given too close to chemotherapy | Give Cegfila at least 24 hours after chemotherapy; not within 14 days before |
| Lithium | Moderate | May potentiate neutrophil release; additive effect on leukocytosis | Monitor white blood cell counts more frequently |
| Topotecan | Major | Prolonged duration of neutropenia if timing is incorrect | Administer Cegfila at least 24 hours after completion of topotecan |
| Bleomycin | Moderate | Possible increased pulmonary toxicity with concurrent G-CSF use | Caution warranted; monitor respiratory function |
| Fluorouracil (5-FU) | Major | Concomitant use may exacerbate neutropenia | Observe standard 24-hour interval between 5-FU and Cegfila |
Major Interactions
The most important interaction is between Cegfila and cytotoxic chemotherapy agents. Because pegfilgrastim stimulates the proliferation of neutrophil precursor cells, administering it too close to chemotherapy drugs (which target rapidly dividing cells) can paradoxically worsen neutropenia. International guidelines from the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) recommend that G-CSFs should be given at least 24 hours after the last dose of chemotherapy and not within 14 days before the next cycle.
Minor Interactions
Lithium, which is used to treat bipolar disorder, has been shown to promote the release of neutrophils from the bone marrow. When used concurrently with Cegfila, there may be an additive effect leading to higher neutrophil counts. While this interaction is generally not dangerous, more frequent monitoring of complete blood counts may be advisable. There are no known interactions with common supportive medications used in cancer treatment, such as anti-emetics (ondansetron, granisetron), corticosteroids (dexamethasone), or standard analgesics (paracetamol, opioids).
What Is the Correct Dosage of Cegfila?
The recommended dose of Cegfila is one 6 mg subcutaneous injection, administered approximately 24 hours after each cytotoxic chemotherapy cycle. This dose is the same for all adult patients regardless of body weight. Cegfila is not recommended for children and adolescents due to insufficient safety and efficacy data in this population.
Cegfila dosing is straightforward compared to many other oncology medicines. The fixed 6 mg dose is based on extensive clinical trial data showing that this dose provides optimal neutrophil recovery across a wide range of body weights (from approximately 45 to 130 kg). The self-clearing mechanism of pegfilgrastim – whereby it is eliminated primarily through neutrophil-mediated uptake rather than renal clearance – means that serum levels naturally decline as the neutrophil count recovers, providing a built-in safety mechanism against excessive neutrophil production.
Adults
Standard Adult Dose
6 mg (one pre-filled syringe) subcutaneously, once per chemotherapy cycle. Administer approximately 24 hours after completion of cytotoxic chemotherapy. Recommended injection sites include the abdomen (at least 5 cm from the navel), the front of the thigh, or the outer area of the upper arm (if administered by a caregiver).
No dose adjustment is required based on body weight, age (within the adult range), or mild-to-moderate renal or hepatic impairment. The dose remains 6 mg regardless of the chemotherapy regimen used, provided that the regimen is associated with a clinically significant incidence of febrile neutropenia. Your oncologist will determine whether prophylactic G-CSF support is indicated based on the specific chemotherapy protocol, your individual risk factors, and international guidelines.
Children
Paediatric Patients
Cegfila is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy. For paediatric patients requiring G-CSF support, daily filgrastim remains the standard of care, with weight-based dosing (typically 5–10 mcg/kg/day). In some countries, pegfilgrastim has been studied in older adolescents weighing over 45 kg, with the adult 6 mg dose used, but this remains off-label for Cegfila specifically.
Elderly
Elderly Patients (≥65 years)
No dose adjustment is required for elderly patients. Clinical trials included patients up to 80 years of age, and no overall differences in safety or efficacy were observed between elderly and younger patients. However, elderly cancer patients are generally at higher risk of febrile neutropenia and its complications, making prophylactic G-CSF support particularly important in this population. Age-related decline in bone marrow reserve may also make older patients more susceptible to prolonged neutropenia.
Missed Dose
If a dose of Cegfila is missed or the administration is delayed beyond the recommended 24-hour window after chemotherapy, contact your oncology team immediately for advice. In general, Cegfila can still be administered later within the same chemotherapy cycle, though the optimal benefit is achieved when given within 24 hours. The decision to administer a late dose or to skip the dose and resume with the next cycle will depend on the timing of the delay and individual clinical circumstances. Do not attempt to make up for a missed dose by taking a double dose.
Overdose
There is limited clinical experience with overdose of pegfilgrastim. In clinical studies, single doses of up to 300 mcg/kg (approximately 18–21 mg for an average adult) have been administered subcutaneously without dose-limiting toxicity. The main anticipated consequence of overdose would be excessive leukocytosis, which is generally asymptomatic but warrants monitoring. In case of suspected overdose, monitor complete blood counts and provide supportive care as needed. There is no specific antidote for pegfilgrastim overdose. Due to the neutrophil-mediated clearance mechanism, serum levels will decline naturally as neutrophil counts rise.
| Patient Group | Dose | Route | Frequency | Notes |
|---|---|---|---|---|
| Adults (18+ years) | 6 mg | Subcutaneous | Once per chemo cycle | Give ~24 h after chemotherapy |
| Elderly (≥65 years) | 6 mg | Subcutaneous | Once per chemo cycle | No dose adjustment needed |
| Children (<18 years) | Not recommended | N/A | N/A | Insufficient paediatric data |
| Renal impairment | 6 mg | Subcutaneous | Once per chemo cycle | No adjustment (not renally cleared) |
| Hepatic impairment | 6 mg | Subcutaneous | Once per chemo cycle | No adjustment required |
What Are the Side Effects of Cegfila?
The most common side effect of Cegfila is bone pain, affecting more than 1 in 10 patients. Other common side effects include musculoskeletal pain, headache, and injection site reactions. Rare but serious side effects include splenic rupture, acute respiratory distress syndrome (ARDS), and severe allergic reactions. Most side effects are manageable and should be reported to your healthcare team.
Like all medicines, Cegfila can cause side effects, although not everybody gets them. The side effect profile of Cegfila is expected to be consistent with that of the reference product Neulasta, as confirmed through clinical trials comparing the two medicines. It is important to distinguish between side effects caused by Cegfila and symptoms related to the underlying cancer or chemotherapy treatment, which can sometimes overlap.
The most frequently reported adverse reaction in clinical trials is bone pain, which occurs as a result of the stimulation of bone marrow activity. This pain is typically mild to moderate, occurs in the limbs, back, or sternum, and resolves within a few days. It can usually be managed effectively with standard analgesics such as paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen. Non-opioid analgesics are generally preferred; however, if pain is severe, your doctor may prescribe stronger pain medication. Some studies suggest that antihistamines (e.g. loratadine) taken prophylactically may help reduce G-CSF-induced bone pain.
It is crucial to report any side effects to your healthcare team, particularly those that are severe, persistent, or unusual. In the European Union, you can also report side effects directly to your national pharmacovigilance authority. This helps in the continuous monitoring of the benefit-risk balance of the medicine.
Very Common
- Bone pain (reported in up to 31% of patients in some trials)
- Musculoskeletal pain (pain in muscles, joints, or limbs)
Common
- Headache
- Nausea
- Injection site reactions (pain, redness, swelling at injection site)
- Fatigue
- Back pain
- Arthralgia (joint pain)
- Myalgia (muscle pain)
- Pain in extremities
- Thrombocytopenia (low platelet count)
- Chest pain (non-cardiac)
Uncommon
- Splenic enlargement (splenomegaly)
- Elevated lactate dehydrogenase (LDH)
- Elevated alkaline phosphatase
- Elevated uric acid
- Skin rash
- Erythema (skin redness)
- Alopecia (hair thinning, typically mild)
- Leukocytosis (excessively high white blood cell count)
Rare
- Splenic rupture (potentially fatal; seek immediate medical attention for left upper abdominal or shoulder pain)
- Acute respiratory distress syndrome (ARDS)
- Anaphylaxis and severe allergic reactions
- Capillary leak syndrome
- Glomerulonephritis
- Sweet syndrome (acute febrile neutrophilic dermatosis)
- Cutaneous vasculitis
- Sickle cell crisis (in patients with sickle cell disease)
- Aortitis (inflammation of the aorta)
- Pulmonary haemorrhage (lung bleeding)
Contact your doctor or go to the nearest emergency department immediately if you experience any of the following while being treated with Cegfila: sudden severe left upper abdominal or shoulder pain (possible splenic rupture), difficulty breathing or shortness of breath (possible ARDS), signs of a severe allergic reaction such as widespread rash, swelling of the face or throat, or breathing difficulties, severe chest pain, or significant swelling of the ankles or legs (possible capillary leak syndrome).
How Should You Store Cegfila?
Store Cegfila in the refrigerator at 2–8°C in its original packaging to protect from light. Do not freeze. If accidentally frozen, discard the syringe. Cegfila may be kept at room temperature (up to 30°C) for a maximum of 72 hours. Do not use after the expiry date on the carton and syringe label.
Proper storage of Cegfila is essential to maintain the stability and efficacy of this biological medicine. Proteins, including pegfilgrastim, are sensitive to temperature extremes and light exposure, which can cause degradation and loss of potency. Following the storage instructions carefully ensures that each dose provides its full therapeutic benefit.
The pre-filled syringe should be stored in the original carton to protect it from light. Keep Cegfila in the refrigerator at a temperature between 2°C and 8°C. Do not place the syringe near the freezer compartment. If the medicine has been accidentally frozen, it must be discarded, even if it has thawed again – freezing can damage the protein structure and compromise the efficacy of the medicine.
If needed, Cegfila may be removed from the refrigerator and stored at room temperature (not above 30°C) for a single period of up to 72 hours. After this period, if the syringe has not been used, it must be discarded and not returned to the refrigerator. Before injection, remove the syringe from the refrigerator and allow it to reach room temperature for approximately 30 minutes. This reduces discomfort at the injection site. Do not warm the syringe using any external heat source such as a microwave or hot water.
Keep this medicine out of the sight and reach of children. Do not use Cegfila if the solution is discoloured, cloudy, or contains visible particles. The solution should be clear and colourless to slightly yellowish. Do not shake the syringe vigorously. Dispose of used syringes in an approved sharps disposal container according to local regulations. Do not dispose of medicines in household waste or via wastewater.
What Does Cegfila Contain?
Each pre-filled syringe of Cegfila contains 6 mg of pegfilgrastim in 0.6 mL of solution. Pegfilgrastim consists of filgrastim (recombinant methionyl human G-CSF) covalently conjugated with a 20 kDa polyethylene glycol (PEG) molecule. The excipients include sodium acetate, sorbitol, polysorbate 20, and water for injections.
The active substance in Cegfila is pegfilgrastim. Pegfilgrastim is produced by recombinant DNA technology in Escherichia coli and subsequently PEGylated (conjugated with polyethylene glycol) to extend its duration of action. The molecular weight of pegfilgrastim is approximately 39 kDa, compared to approximately 19 kDa for unconjugated filgrastim. This increased molecular size reduces renal clearance and allows the predominantly neutrophil-mediated clearance pathway to regulate serum levels.
Each 0.6 mL pre-filled syringe contains:
- Active substance: Pegfilgrastim 6 mg (corresponding to 10 mg/mL)
- Sodium acetate trihydrate: Buffer to maintain pH stability
- Glacial acetic acid: pH adjustment agent
- Sorbitol (E420): Stabiliser and tonicity agent
- Polysorbate 20: Surfactant to prevent protein aggregation
- Water for injections: Solvent
The syringe needle cover contains dry natural rubber (a derivative of latex). Patients with a known latex sensitivity should inform their healthcare provider before administration, as allergic reactions may occur. The pre-filled syringe is fitted with a staked needle and needle guard. The solution is clear and colourless to slightly yellowish, and should be free from visible particulate matter.
Cegfila contains sorbitol (E420). The amount of sorbitol per dose is small (approximately 30 mg per syringe) and is unlikely to cause digestive problems. However, patients with hereditary fructose intolerance should not use this medicine, as sorbitol is metabolised to fructose. Consult your doctor if you have been told you have an intolerance to some sugars.
Frequently Asked Questions About Cegfila
Cegfila (pegfilgrastim) is used to reduce the duration of neutropenia (low white blood cell count) and the incidence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving myelosuppressive cytotoxic chemotherapy. By stimulating the bone marrow to produce more neutrophils, Cegfila helps protect patients from serious, potentially life-threatening infections during chemotherapy treatment. It is a biosimilar of the well-established reference product Neulasta.
Cegfila is given as a single 6 mg subcutaneous (under the skin) injection approximately 24 hours after each chemotherapy cycle. It comes in a pre-filled syringe and can be injected into the abdomen (at least 5 cm from the navel), the front of the thigh, or the outer area of the upper arm. After proper training by a healthcare professional, patients or their caregivers can self-administer the injection at home. The first dose is typically given under medical supervision.
The most common side effect is bone pain, which affects more than 1 in 10 patients. This occurs because Cegfila stimulates rapid bone marrow activity. Other common side effects include musculoskeletal pain, headache, nausea, injection site reactions, and fatigue. Most side effects are mild to moderate and temporary. Bone pain can usually be managed with over-the-counter pain medications such as paracetamol (acetaminophen) or ibuprofen. Consult your doctor if side effects are severe or persistent.
Cegfila is a biosimilar of Neulasta, meaning it is a biological medicine that has been developed to be highly similar to the reference product. Both contain the same active substance (pegfilgrastim) at the same dose (6 mg). Comprehensive studies have confirmed that Cegfila is equivalent to Neulasta in terms of quality, safety, and efficacy. The EMA has approved Cegfila after a thorough biosimilar evaluation process. Biosimilars help increase access to important biological therapies while offering potential cost savings.
Yes, after proper training by a healthcare professional, Cegfila can be self-administered at home using the pre-filled syringe. Patients or their caregivers should receive instruction on the correct injection technique, how to choose and rotate injection sites, proper storage conditions, and safe disposal of used syringes in a sharps container. It is important to remove the syringe from the refrigerator about 30 minutes before injection to allow it to reach room temperature, which reduces injection site discomfort.
Cegfila should be stored in a refrigerator at 2–8°C in its original packaging to protect from light. Do not freeze. If accidentally frozen, discard the syringe even if it has thawed. Cegfila may be kept at room temperature (not above 30°C) for a single period of up to 72 hours. After this time, if unused, it must be discarded and not returned to the refrigerator. Always check the expiry date and inspect the solution before use – it should be clear and colourless to slightly yellowish.
References and Sources
This article is based on the following evidence-based sources. All medical claims have been verified against international guidelines and peer-reviewed research:
- European Medicines Agency (EMA). Cegfila – Summary of Product Characteristics. EMA/CHMP. Available at: www.ema.europa.eu
- European Medicines Agency (EMA). Neulasta (pegfilgrastim) – EPAR Product Information. First authorised 2002. Available at: www.ema.europa.eu
- Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199-3212. doi:10.1200/JCO.2015.62.3488
- Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8-32.
- Lyman GH, Yau L, Nakov R, Krendyukov A. Overall survival and risk of second malignancies with cancer chemotherapy and G-CSF support. Ann Oncol. 2018;29(9):1903-1910.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 1.2025.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023. Available at: www.who.int
- Blackwell K, Semiglazov V, Krasnozhon D, et al. Comparison of EP2006, a filgrastim biosimilar, to the reference: a pharmacokinetics, pharmacodynamics and efficacy equivalence study. Br J Cancer. 2015;113(4):605-611.
- European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. EMEA/CHMP/BMWP/42832/2005 Rev1.
- Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol. 2012;7(Suppl 1):S57-S67.
About Our Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in oncology, haematology, and clinical pharmacology. Our team follows a rigorous editorial process based on the GRADE evidence framework, ensuring that all medical information is accurate, up-to-date, and based on the highest quality of evidence.
Medical Writing
Written by qualified medical writers with expertise in oncology pharmacotherapy, based on EMA-approved product information, international treatment guidelines, and peer-reviewed clinical literature.
Medical Review
Reviewed by the iMedic Medical Review Board, comprising practising oncologists and clinical pharmacists who verify the clinical accuracy and relevance of all content.
Evidence Standards
All claims are graded using the GRADE framework. Sources include EMA SmPCs, ASCO/NCCN guidelines, ESMO recommendations, WHO essential medicines list, and peer-reviewed systematic reviews.
Editorial Independence
iMedic operates independently without pharmaceutical industry sponsorship or commercial funding. Our content is free from conflicts of interest and is produced solely for educational purposes.