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Viatris’ Once-Monthly Copaxone Filing Imminent, Botox ‘On Track’

Recent Approval For Revance Brand Encourages Viatris On Botox

 
• By Dean Rudge

Fresh from offloading almost all its interests in biosimilars to Biocon, Viatris continues to develop several follow-on products, which it hopes will add $1bn to the company’s top line by the end of the decade.

multiple sclerosis
Viatris is looking to expand its MS portfolio • Source: Alamy

Viatris remains confident of filing its proposed once monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for multiple sclerosis, in the US during Q1 following the recent conclusion of a pivotal Phase III clinical trial.

Subject to regulatory timelines, Viatris believes that it could launch the proposed 505(b)(2) glatiramer acetate product in 2024.

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More from Value Added Medicines

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

‘Disappointed’ Lipella Seeks Alternatives Following Nasdaq Delisting

 
• By Dean Rudge

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Hyloris Secures US Approval For Avenacy-Partnered RTU Tranexamic Acid

 
• By Adam Zamecnik

After signing a deal with Avenacy at the end of last year, Hyloris has now announced the approval of its intravenous formulation of tranexamic acid, which is used as a hemostatic agent.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
• By Dave Wallace and Dean Rudge

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

More from Products

Biocon Agreement Provides Multiple Oncology Biosimilars To Malaysian Cancer NGO

 
• By Dean Rudge

Biocon Biologics will look to combine its “scientific expertise with the National Cancer Society of Malaysia’s strong community outreach and patient support network,” after signing striking up a partnership with the NGO providing for supply of three biosimilars.

Cigna Claims BMS Tied Revlimid Settlements to Pomalyst ‘Pay-for-Delay’ Scheme

 
• By Dean Rudge

Among other schemes, Cigna alleges that Celgene and parent Bristol Myers Squibb “paid” generic challengers – via lucrative Revlimid profit-sharing agreements – to delay generic market entry for Pomalyst until 2026, unlawfully extending their monopoly and overcharging purchasers.

US Supreme Court Requests Solicitor General Input On Hikma Skinny Label Case

 
• By Dean Rudge

The US Supreme Court is seeking a brief “expressing the views of the United States,” following the US Federal Circuit’s decision to reopen Amarin’s claim of induced infringement against Hikma relating to its ‘skinny-label’ generic Vascepa (icosapent ethyl) product.