Could Pfizer's at-risk Inflectra launch set a biosimilars precedent for Amgen, Novartis?

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Good news for biosimilar drugmakers: Pfizer’s decision to launch its Remicade knockoff at-risk may make their own rollouts more secure.

With U.S. biosimilars law taking shape in real time, the legal back-and-forth between the New York drugmaker and Remicade manufacturer Johnson & Johnson could set precedents for future cases, EP Vantage notes--and biosimilar challengers such as Amgen and Novartis stand to benefit.

Pfizer and partner Celltrion based their launch decision, which they announced last week, on the assumption that J&J’s remaining IP protection on Remicade wouldn't withstand a court challenge. If it does, Pfizer will owe damages to J&J, and lots of them.

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But if Pfizer’s right, and the IP doesn’t hold up? Pfizer will have hit the market with Inflectra earlier than otherwise, and the verdict may bode well for its copycat peers. Amgen, for one, will have to beat back AbbVie’s Humira defense if it wants to launch the already FDA-approved Amjevita, and Novartis has a similar task ahead with its green-lighted copy of Amgen’s Enbrel, Erelzi.

Of course, all the reference meds are different, and they have different IP shields lined up against their biosimilar nemeses, meaning that what happens with Inflectra may not hold for the rest of the field. But on the other hand, Pfizer may just be taking one for the biosimilars team.

Meanwhile, J&J says it's confident that it can hang on to Remicade market share when Inflectra hits the scene. Remicade’s market is already an “extremely competitive” one on price, and the company intends to develop “innovative contracts” with payers to “utilize the full breadth” of its portfolio,” execs said last week on the company’s Q3 conference call.

Plus, 70% of patients are stable on the med, and execs feel confident that they won’t be jumping ship.

Data from a new switching study may help change their minds, though. In an independent Phase IV study sponsored by the Norwegian government, Celltrion’s ex-U.S. Remicade biosim Remsima kept disease from worsening just as well as its reference product in patients who'd been stable on Remicade for at least 6 months before the switch. 

Related Articles:
Remicade patients OK to switch to biosim, study shows, as Pfizer gears up for rollout
Pfizer loads up for Remicade biosim launch, with $4.5B J&J brand in its sights
J&J braces for biosim attack after losing last-ditch Remicade patent fight
Celltrion, Pfizer win FDA OK for biosimilar of J&J's Remicade
J&J updates on Celltrion Remicade biosimilar in U.S. outlook with October date
Pfizer cautious on Remicade biosimilar U.S. launch after J&J blast
J&J pooh-poohs threat from Remicade biosim this year

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