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  2. >>Biosimilars & Generics
  3. >>Generics

Brands Push Back Against REMS Reform, Call Problem Small With Burdensome Fixes

 
• By Michael Cipriano

BIO cautioned that its members may have difficulties meeting the purchase orders of product for generic sponsors, while PhRMA contended legislation is not necessary.

Although the US FDA can send letters to brand companies on behalf of generic sponsors seeking samples of drugs covered by risk evaluation and mitigation strategies (REMS), innovators are cautioning there are other components to account for that make providing samples difficult.

John Murphy, deputy general counsel for the Biotechnology Innovation Organization (BIO) contends that the organization's smaller members have raised concerns...

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More from Generics

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

GDUFA IV Talks Begin, Embracing Traditional Process

 
• By Derrick Gingery

The introductory meeting did not suggest changes to the expected schedule and operations for renewing the generic drug user fee, said AAM’s Giuseppe Randazzo.

US FDA’s ANDA Prioritization Pilot Encouraging Production Onshoring

 
• By Dave Wallace

The latest incentive for firms to move manufacturing to the US is an FDA pilot program that will prioritize the review of US-manufactured and tested ANDA products.

More from Biosimilars & Generics

Biosimilar Interchangeability Guidance Eliminating Switching Studies Coming Soon

 
• By Cathy Kelly

The guidance is part of the FDA’s effort to encourage more biosimilar development by streamlining approval requirements and lowering development costs.

US FDA’s Makary Wants Lower Biosimilar Launch Prices As Clinical Study Mandate Changed

 
• By Derrick Gingery

The new guidance says comparative clinical trials are not a prerequisite for all biosimilars, a notable step for the FDA, but the commissioner added that biosimilar prices should be significantly lower than the reference product at launch.

Biosimilars: US FDA Regulatory Science Research ROI Still To Be Determined

 
• By Derrick Gingery

FDA officials said the pilot program needs more time to determine its return on investment as user fee renewal talks near.