Mini-Exodus From Biosimilar Space Stirs Questions

Regulatory NewsRegulatory News
| 06 December 2018 | By Zachary Brennan 

In just the past month, three companies have all exited the biosimilar space in one way or another, which has some questioning whether expectations for the biosimilars markets need to be adjusted.

The slide began early last month when Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information.

Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said he believes the needs of the marketplace for rituximab “will be satisfied before we can generate the data required.” His comment came just before the approval of Celltrion and Teva’s rituximab biosimilar. And Pfizer is expecting a decision on its rituximab biosimilar in the second quarter of 2019.

In addition to Sandoz, Boehringer Ingelheim, still locked in litigation with AbbVie over its already-approved Humira (adalimumab) biosimilar in the US, said it was abandoning all biosimilar development work outside the US. The company also said it will not commercialize its already-approved Humira biosimilar in the EU.

And Oncobiologics earlier this week announced it was changing its name to Outlook Therapeutics and is no longer pursuing its bevacizumab and adalimumab biosimilars.

So, what do the three decisions amount to, especially considering they run the gamut from established (Sandoz) to niche (Oncobiologics) biosimilar developers? And should one expect to see more companies pulling away from biosimilars?

At least one expert believes larger biopharma companies will exit the space rapidly once biosimilar prices come down. But biopharma companies have not said as much publicly, and others think the industry is in more of a watch-and-wait mode right now.

Gillian Woollett, senior vice president of Avalere Health, told Focus: “I think we need to hear what the data is telling us—and US expectations for a sustainable and competitive market may need to be adjusted as a result.”

Indeed, just six of the 15 biosimilars approved in the US have reached the market, and some have only captured a small fraction of the share that competitors have cornered in Europe.

Nowhere is the difference between Europe and the US biosimilar markets more apparent than in the race to bring competition for AbbVie’s blockbuster Humira. Seven companies have now settled with AbbVie to wait until 2023 to launch their biosimilars in the US (Boehringer would be the eighth), while in the EU, four have already launched, bringing discounts as high as 80% in some Nordic markets.

“The discounting is coming in 10 points higher than what we would’ve anticipated,” AbbVie CEO Rick Gonzalez said, noting the company is expecting to see about 25% of its Humira sales erode in Europe and internationally in 2019.

And outside of Humira, there are other markets where the EU has seen a rise in biosimilars while the US has not seen any competition.

For instance, biosimilars for Amgen’s Enbrel (etanercept) have nabbed 40% market share in the EU, while in the US, Sandoz’s Erelzi (etanercept-szzs) was approved in August 2016 but has yet to come to market. Similarly, Herceptin (trastuzumab) and Rituxan (rituximab) biosimilars have seen strong adoption across the EU and no adoption in the US.

But it isn’t all doom and gloom in the US. Adoption of Neupogen (filgrastim) biosimilars is progressing, reaching 60% of market share, and FDA has approved more biosimilars in 2018 than any year prior.


© 2022 Regulatory Affairs Professionals Society.

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