Indian company first to the finish line with historic Humira biosimilar
- Indian pharmaceutical Zydus Cadila has officially won the race to become the first company in the world with an approved biosimilar of AbbVie's Humira, the top-selling drug in the world.
- The drug will be marketed as Exemptia and has been indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis.
- According to Business Standard, Zydus Cadila has 24 biologics (including biosimilars and novel biologics) in the pipeline. Exemptia will cost just $1,000 per vial in India—one-fifth of what Humira's price in the country.
This is a major victory for Indian pharma and inflammatory disease patients in the poor nation. But what remains to be seen is if the sorts of manufacturing practice and clinical data problems that have been plaguing chemical generic drug manufacturers in the country will spill over into the biosimilars sector. France, Germany, and several other EU countries have suspended approval of at least 25 Indian generic drugs over clinical trial data concerns.
Amgen and Novartias subsidiary Sandoz also have Humira biosimilars in the works. They are both currently in phase III development.
- Business Standard Zydus Cadila launches biosimilar of Adalimumab
- BioPharma Dive Look out, AbbVie: Here comes Amgen's Humira biosimilar
- BioPharma Dive France, Germany, other EU countries suspend Indian generics approvals