Biogen BIIB announced that the European Medicines Agency (EMA) has accepted its biosimilar candidate, SB2 for review. SB2 is the biosimilar of Remicade. The company is looking to get SB2 approved for all the indications of Remicade which include rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis, and psoriasis. Biogen has an agreement with Samsung Bioepis for SB2.
We note that this is the second marketing application validated for review by the EMA as part of the joint venture between Biogen and Samsung Bioepis, following that of SB4 (biosimilar of Enbrel), which was validated for review earlier this year.
Biosimilars are expected to reduce healthcare costs and provide a large number of patients with access to much needed biologic treatments. While biosimilars have been available in the EU for quite a while, the scenario was different in the U.S. due to regulatory reasons. However, the biosimilar situation in the U.S. has changed with the FDA approving Sandoz’s (a Novartis NVS company) Zarxio, a biosimilar of Neupogen.
The biosimilar market represents significant commercial potential and several companies are trying to get a foothold in this market. A major player in the biosimilars market is Hospira Inc. HSP which has launched several biosimilars like Retacrit (EPO), Nivestim (Neupogen) and Inflectra (Remicade) in Europe and is now looking to get Retacrit and Inflectra approved in the U.S.
We are encouraged by Biogen’s effort to bring biosimilars to the market.
Biogen is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Cambrex Corp. CBM, sporting a Zacks Rank #1 (Strong Buy).