Fulphila Approved as First Biosimilar to Neulasta
June 5, 2018 – The U.S. FDA has approved Fulphila™ (pegfilgrastim-jmdb), manufactured by Mylan and Biocon, to lower the incidence of infection in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
Fulphila is the first biosimilar to Amgen’s Neulasta® (pegfilgrastim) to win FDA approval. Like other biosimilars, it is not automatically interchangeable with its reference product. However, it may offer a more affordable treatment option for patients.
Recommended dosing for adults is 6mg administered by subcutaneous injection once per chemotherapy cycle. Dosing for pediatric patients is based on weight. Fulphila should not be administered for 14 days before or 24 hours after cytotoxic chemotherapy. The product will be available in single-dose pre-filled syringes for manual administration.
The product has not yet been launched, and pricing plans are not currently available.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.