Drug Development

FDA hands Novartis the keys to a $5B Amgen franchise

Novartis has bagged an FDA approval for Erelzi (etanercept-szzs), its biosimilar of Enbrel. And now the pharma giant is good to go on every indication Enbrel is marketed for in the U.S. including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Carol Lynch, Sandoz Global Head of Biosimilars

Carol Lynch, Sandoz

The approval gives Novartis the keys to a market worth $5 billion a year to Amgen, which tried to block this wide-ranging regulatory OK in the key US market. The fight is likely far from over though. Amgen has moved its rear-guard action to the courts, a strategy which has proven far more effective in blocking this first wave of biosimilars and the discounts they promise.

Novartis has now scored two of the first three biosimilar approvals in the U.S. And it has plans for many more. In the process, they’ve helped blaze a big trail for a group of biosimilar developers making knockoffs for some of the biggest blockbusters on the market. One of the big considerations has been the FDA’s clear preference for extrapolating data on one indication for the full slate of approvals the branded drug maker gained with years of research work.

The key is the similarity of the drugs. Once the biosimilar manufacturer has pegged that with convincing late-stage data, the rest falls into place—at least among these original players. And fighting extrapolation appears to be a losing strategy for anyone playing defense.

But it hasn’t all been clear sailing for Novartis. Back in July, the company had to concede that the FDA had rejected its copycat of Neulasta, though it didn’t offer any reason for the move. It’s proven far more forthcoming about this new approval.

“Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas,” noted Carol Lynch, Global Head Biopharmaceuticals, Sandoz. “We are committed to bringing Erelzi to the US market as soon as possible”.

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