Inflectra is the first and only biosimilar monoclonal antibody (mAb) therapy and only the second biosimilar to be launched in the U.S. Pfizer plans to start shipments to wholesalers at a 15% discount to Remicade’s present wholesale prices.
Inflectra is approved for use across all eligible indications of the reference product, Remicade, which include reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
Remicade scooped up sales of $2.9 billion (including U.S. exports) in the U.S. in the first six months of 2016 and $4.5 billion (U.S.) in 2015.
We remind investors that Celltrion’s biosimilar version of Remicade, Inflectra, had gained FDA approval in April. Pfizer has exclusive commercialization rights to Inflectra in the U.S. and certain other territories. Inflectra is already available in Europe and many other markets outside the U.S.
In August, the District of Massachusetts Federal Court ruled in favor of Celltrion and Hospira in an ongoing patent dispute with J&J and said that U.S. Patent No. 6,284,471 for Remicade ('471 patent) is invalid. J&J then said it intends to appeal the decision (Read: J&J Remicade Patent Invalid, Pfizer to Launch Inflectra?).
Pfizer’s launch would be before a resolution to the dispute.
Pfizer’s Sep 2015 Hospira acquisition expanded its portfolio of biosimilars. Notably, biosimilars of Herceptin, Rituxan/MabThera, Avastin and Humira are in phase III development while biosimilars of Neupogen and Neulasta are in phase I. Pfizer believes that the market for biosimilars is huge and can grow to $17–$20 billion by 2020.In the second quarter of 2016, Pfizer recorded biosimilars revenues of $78 million.
In fact, the pharmaceutical industry is set for the approaching wave of biosimilars, which are essentially generic versions of expensive biologic drugs.
Several pharma as well as biotech companies are involved in the development of biosimilars. The first biosimilar to gain approval in the U.S. was Sandoz’s (Novartis AG’s NVS generic arm) Zarxio, a biosimilar version of Amgen Inc.’s AMGN Neupogen. Zarxio was launched in the U.S. in Sep 2015.
Other approved biosimilars include Sandoz’s Erelzi, a biosimilar to Amgen’s Enbrel (etanercept) and Amgen’s Amjevita, a biosimilar version of Abbvie’s Humira.
Several other companies like Merck, Biogen and Allergan are also targeting the highly lucrative biosimilars’ market.
J&J and Pfizer are both Zacks Rank #3 (Hold) stocks. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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