On Friday, German drugmaker Boehringer-Ingelheim received news the Biologics License Application (BLA) for Cyltezo (adalimumab-adbm) has been approved by the US Food and Drug Administration (FDA).
The product is a biosimilar of the rheumatoid arthritis biologic Humira, which last year clocked in over $10.4bn in US sales alone for reference drugmaker AbbVie. It is also the second adalimumab biosimilar to be approved by the Agency after Amgen’s Amjevita received the regulatory thumbs up last September.
But a year on Amgen is yet to have announced an Amjevita launch date due to ongoing litigation with AbbVie, and a spokesperson from Boehringer-Ingelheim was similarly guarded as to when Cyltezo could be available for US patients.
“Although we cannot disclose exact timings for a commercial availability, we are working diligently to provide our biosimilar to patients at the earliest possible time,” Biopharma-Reporter was told over email.
AbbVie has been vocal about its web of patents covering the formulation, manufacturing and method of treatment for Humira, which it says will protect the bestseller from biosimilar competition until at least 2022.
However, a series of legal challenges have chipped away at some of the key patents and biosimilar makers are confident of an earlier launch date, both in the US and in Europe where Boehringer-Ingelheim told us it expects an opinion on the marketing authorization application for its adalimumab candidate later this year.
Boehringer-Ingelheim said it was unable to comment on the manufacturing of Cyltezo, but according to the FDA’s approval letter it will be made at the firm’s facility in Fremont, California.
The site makes both Boehringer-Ingelheim’s own biologics as well as others as a contract manufacturing service and last month the firm announced it would expand and upgrade the facility through a $217m investment, adding 300 jobs in the process.
Since March 2015, the US FDA has approved six biosimilar products:
- March 2015: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen
- April 2016: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade
- August 2016: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel
- September 2016: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira
- April 2017: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade
- August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira
None of these products have been deemed interchangeable – a designation that means a biosimilar may be substituted by a pharmacist for the reference product without the intervention of the healthcare provider – by the FDA, but Boehringer-Ingelheim last month began a clinical study on the interchangeability between its adalimumab biosimilar candidate and Humira.