Sandoz Enbrel biosim cruises at FDA panel, endangering key Amgen sales


In the second straight resounding vote in favor of a biosimilar in as many days, Sandoz’s version of Amgen’s Enbrel earned unanimous support from an FDA panel Wednesday.

With the 20-0 vote, Novartis’ generics unit advances in its crusade toward a potential big sales boost and a second biosim on the U.S. market that’s just getting acquainted with the biosimilar concept. Dubbed GP2015, Sandoz’s Enbrel biosim looks “highly similar” to the original product, FDA staffers said earlier this week, and could now be in a position to take a big bite out of the California company’s $5.1 billion in sales from its anti-TNF blockbuster.

Prior to the meeting, FDA staffers said they considered there to be “sufficient scientific justification” in extrapolating psoriasis biosimiliarity data to other indications Sandoz is seeking in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis, they said. The committee agreed, recommending the biosim for all of Enbrel’s approved indications. The FDA doesn't always follow committee recommendations, but it typically does.


De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

Wednesday, July 8, 2020 | 11am EST / 8am PST

This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.

Wednesday’s meeting represented the second straight day an FDA expert committee unanimously supported a biosimilar following Tuesday’s vote in favor of Amgen’s copy of AbbVie rheumatoid arthritis megablockbuster Humira. This time, though, it’s Amgen fending off biosimilar competition while Sandoz inches forward in the field.

The Swiss pharma’s generics outfit is betting big in biosims, saying recently it’s shooting to market 5 by 2020 in the U.S. and other “key geographies.” It’s planning to submit 11 regulatory filings by the end of 2017 and expects to gain approval for copies of Enbrel, Humira, Neulasta from Amgen, Remicade from Johnson & Johnson and Merck, and Rituxan from Roche. The company is already blazing a path with the first U.S.-approved biosim in Zarxio, a copy of Amgen’s Neupogen.

- here's Sandoz's release

Related Articles:
FDA staffers like Sandoz' biosimilarity data for copy of Amgen's Enbrel
Novartis' Sandoz aims for 5 biosim launches by 2020
Novartis finally gets to roll out inaugural biosim Zarxio. What will payers and docs do?
In unanimous vote, FDA committee backs Amgen's Humira biosim


Suggested Articles

Johnson & Johnson will shell out at least $480 million to Emergent BioSolutions to produce millions of doses of its COVID-19 vaccine hopeful.

Despite the many HIV drugs available, some patients still can’t be successfully treated because they're drug-resistant. Now, they have a new option.

Sanofi and Regeneron have stopped their U.S. trial for Kevzara in COVID-19 after the drug showed no benefit in treating ventilated patients.