Sandoz, the generic pharmaceuticals division of Novartis, is the global leader in biosimilar products. On March 6, 2015, FDA approved Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim) from Sandoz. This was the first biosimilar product to receive FDA approval in the US (more details in our blog posts here and here). Since its approval, there have been a plethora of headlines highlighting the two companies; including a battle in court over Novartis’ right to sell Zarxio, which Novartis ended up winning.
Sandoz has announced another biosimilar version of one of Amgen’s products, Enbrel (entanercept), an anti-TNF medicine used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis. Last week, FDA announced that it would review the company’s application using the 351(k) pathway, just as the company did with Zarxio.
According to a recent Sandoz announcement, the company believes that its two pivotal studies should prove that the biosimilar is virtually the same as Amgen’s product. Sandoz also stated that it would be seeking approval for all of the autoimmune disease indications of Amgen’s drug.
There are currently two biosimilar versions of Enbrel approved in South Korea, one from Merck and another from Samsung Bioepis. Additionally, Samsung and Biogen are both in the process of bringing biosimilar versions of the drug to the EU.
Are you working on developing a biosimilar product? Do you have a biosimilar product that you would like to obtain US approval for? We can help get your product approved by FDA. Our unique approach, which combines a deep scientific knowledge with regulatory expertise, has a history of helping our clients achieve successful outcomes with FDA. To learn more about how we can help get your product through FDA, please contact us.