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US Biosimilars Enjoy A Year Of Firsts In 2021

Two Interchangeable Biosimilars And First Ophthalmic Biosimilar Approved

 
• By Dave Wallace

While US biosimilar approvals have been somewhat thin on the ground in 2021 – with multiple products seeing action delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.

Eye USA Flag Face
The first US ophthalmic biosimilar was among 2021’s approvals • Source: Antony McAulay / Alamy Stock Photo

With biosimilars increasingly gaining traction in the US in recent years thanks to multi-source competition on certain key products, as well as healthy uptake in treatment areas such as oncology, 2021 saw the US biosimilars market take further steps forward with a number of firsts.

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• By Eleanor Malone

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Is Towa’s Guidance For 2024 ‘Somewhat Mediocre?’

 
• By Dean Rudge

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• By Generics Bulletin Team

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Sandoz And Henlius Join Forces With $300m Ipilimumab Deal

 
• By Dave Wallace

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

Discounted Ustekinumab Biosimilars Further Dent J&J’s Q1 Stelara Sales

 
• By Urtė Fultinavičiūtė

With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.

Speranza Starts Generics Offshoot In Response To Wider US Pharma Manufacturing Drive

 
• By Adam Zamecnik

Reflecting increased regulatory pressure and a wider drive towards the reshoring of pharmaceutical manufacturing to the US, Speranza has launched a new generics business called Lotus Therapeutics.