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Amgen's Avastin Biosimilar May Revive Orphan Indication Concerns

 
• By Derrick Gingery

Questions about US FDA's handling of orphan indications may arise again during upcoming Oncologic Drugs Advisory Committee meeting on ABP215, a proposed Avastin biosimilar.

Digital illustration of Cancer cell in colour background

Amgen Inc. again may face concerns about damage to orphan drug incentives when its proposed biosimilar of Genentech Inc.'s Avastin (bevacizumab) comes before the US FDA's Oncologic Drugs Advisory Committee.

Amgen and partner Allergan PLC are seeking approval of ABP215 for six of Avastin's indications. (See box.) But two...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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More from Regulatory Trackers

Global Pharma Guidance Tracker - April 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.