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Business & Regulation Biosimilars, Business Practice, Standards & Regulation

A Warm Welcome to Biosimilars

It’s been a rocky road for biosimilars. The FDA approved its first biosimilar in March 2015. Six years on, only 30 other biosimilars have been approved. The FDA only approved three biosimilars in 2020, and 2021 looks to be another slow year with only three approvals at the time of writing (November 2021) – at least on the surface...

In reality, it could represent a big turning point. Two of the three biosimilars approved so far are “interchangeable” with their reference products, which could allow for automatic substitution at pharmacies.

In June, the FDA approved Mylan’s Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar insulin for Lantus. In a statement released at the time, Janet Woodcock from the FDA said, “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

In October, the FDA approved an interchangeable biosimilar to Humira (adalimumab): Boehringer Ingelheim’s Cyltezo.

It’s possible that there could be pushback from patients but that will depend a great deal on the positioning.

Other biosimilars to Humira have already been approved by the FDA, but the interchangeable designation will put Cyltezo in a strong market position. Notably, none of these Humira biosimilars will likely reach the market until 2023, as Humira is protected by patents until then. One company, Alvotech, has chosen to fight Abbvie’s patents in court rather than through an agreement, so it’s possible a biosimilar could be launched sooner, but Alvotech hasn’t yet received any approval for its biosimilar...

The introduction of interchangeable biosimilars will certainly change the market in the US, but many hurdles are likely to lie ahead. Each US state has its own laws around interchangeable biosimilars, with many requiring the patient to be notified before any substitution occurs; it’s possible that there could be pushback from patients but that will depend a great deal on the positioning.

The EMA got off to a head start by approving its first biosimilar back in 2006 – but Europe isn’t exactly swimming in biosimilars either; just over 60 have since been approved. There are various reasons for the slow progress – some of which are outlined in my interview with Sandoz’s Pierre Bourdage

Given that biosimilars can deliver significant cost savings to patients, every new one successfully approved deserves fanfare. The third biosimilar to be approved by the FDA in 2021 is Samsung Biopepis’ Byooviz (ranibizumab-nuna) – a biosimilar to Lucentis. Welcome to the market, Byooviz and Semglee! And a (pending) welcome for Cyltezo and other Humira biosimilars for 2023.


This article is based on short posts I wrote for The Bioprocess Curator. Subscribe here.

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About the Author
Stephanie Sutton

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

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