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Mylan's Herceptin Advisory Committee May Be First Bumpy One For A Biosimilar

 
• By Derrick Gingery

US FDA did not address production problems in its briefing document for upcoming Oncologic Drugs Advisory Committee meeting, but manufacturing deficiencies found at Biocon's facility could prompt questions.

Digital illustration of Cancer cell in colour background

Mylan NV's proposed biosimilar of Genentech Inc.'s Herceptin (trastuzumab), appears to have met all of FDA's requirements for approval, but the sponsor still may have to answer questions about its development partner's manufacturing issues.

FDA's overall conclusion was that the totality of evidence suggests that MYL-1401O is highly similar to US-approved Herceptin notwithstanding minor...

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More from Biosimilars

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By Dean Rudge

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

Samsung Bioepis Finds New US Partner For Ophthalmic Biosimilars

 
• By Dave Wallace

Samsung Bioepis has announced a fresh ophthalmic biosimilars partnership with Harrow, as the end approaches for a longstanding US commercialization alliance with Biogen on the Korean firm's Lucentis (ranibizumab) and Eylea (aflibercept) rivals Byooviz and Opuviz.

‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

More from Products

ViiV Extends Voluntary License For Long-Acting Cabotegravir As HIV Treatment

 
• By Urtė Fultinavičiūtė

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.