After strong FDA panel backing, Celltrion & Pfizer's Remicade copycat could become 2nd US biosim
- An expert advisory panel to the FDA on Tuesday overwhelmingly voted to recommend that the agency approve Celltrion & Pfizer's Remsima, a copycat of Johnson & Johnson's blockbuster anti-inflammatory biologic Remicade.
- Remicade notched $4.5 billion in sales in U.S. sales last year.
- The FDA approved the first biosimilar in America last year, Novartis' Zarxio (a copycat of Amgen's Neupogen).
The strong panel backing suggests that FDA advisers are becoming more open to moving biosimilar treatments through the regulatory process. While biosims have been common in other markets for years, there are still big questions surrounding their approval pathways and possible legal issues in the U.S.
Biologics makers won't take the competition lying down, either. As the Wall Street Journal reports, companies like Humira-maker AbbVie have been ramping up efforts to prevent biosimilar market entry by pursuing additional patents on older drugs. Humira itself has approximately 70 patents associated with it, and AbbVie expects these patents to keep copycats out of the way until 2022.
Companies like Amgen, Novartis, Samsung Bioepis, and others are pursuing approvals for biosimilars of some of the best-selling biologics in the world, including Humira, Herceptin, and even the Sanofi insulin Lantus. And last month, Samsung Bioepis scored the first-ever approval in the EU for a biosimilar of Amgen's anti-inflammatory best-seller Enbrel.