FDA

A brochure for Amneal’s Alymsys biosimilar bevacizumab rival to Avastin has caught the attention of the US Food and Drug Administration’s Office of Prescription Drug Promotion.

Matt Erick, chief commercial officer for advanced markets at Biocon Biologics, told Generics Bulletin why he foresees consolidation on the way in the US biosimilars sector – but also why no single company can try and tackle the whole market on its own.

Outlook will be meeting again with the FDA to discuss the approval of its ophthalmic formulation of bevacizumab. However, this time, Outlook will go through a different procedural pathway.

Fresh from taking over the role of AAM chair, Lupin’s Bob Hoffman talks to Generics Bulletin about how the “squeezed” US off-patent industry is having to work hard just to remain sustainable – and the messages that US policymakers need to hear.

The US FDA’s latest annual budget request includes proposals that would allow firms to file Paragraph IV ANDAs more quickly if they manufacture in the US, as well as to make it easier to develop generic drug-device combinations and to deem all biosimilars interchangeable.

The FDA said chronic under-collection of GDUFA revenue could create budget problems going forward unless the system is changed, but industry does not want to endanger the generic sector with higher fees.

Celltrion has amended its CT-P51 pembrolizumab Phase III trial as it moves to capitalize on evolving FDA biosimilar guidance, aiming to cut development costs and timelines while aligning with an emerging industry shift toward streamlined clinical requirements.

The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.

FDA feedback following a January type 2a meeting supports Aeon’s analytical strategy for its Botox biosimilar, providing a clearer roadmap to complete comparability work in 2026 and shaping the next phase of regulatory engagement.

Sponsors thought a shorter goal date extension was appropriate if a facility received the unofficial potential Official Action Indicated tag, but the FDA said it needs the extra time to complete the final steps in the application review.

Despite recent wins on streamlining and interchangeability, the US biosimilars industry continues to face challenges such as IRA price negotiation, dysfunctional pricing dynamics and PBM distortions, says AAM Biosimilars Council chief Alex Keeton.

Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.

After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.

The US FDA released one of the highest numbers of product-specific guidances for generic development in a single batch.

The latest biosimilars guidance from the FDA – which promises to further streamline applications by making it easier for developers to rely on non-US comparator products – has been warmly received by the off-patent industry.

As the US biosimilars market continues to evolve, Cardinal Health’s director of biosimilars Dracey Poore talks to Generics Bulletin for an exclusive Q&A.

At the AAM’s Access! 2026 conference, a dedicated panel on the latest developments for biosimilars discussed challenges and opportunities in the US market, predicting consolidation among current players as well as calling for policies that put biosimilars first.

The FDA offered to relax the onshoring criteria to receive a priority ANDA review in GDUFA IV, but could drop another America First proposal.

Glenmark says it plans to launch imminently the first US generic fluticasone propionate rival to Flovent, for which it has just received FDA approval – with an added bonus of 180 days of Competitive Generic Therapy exclusivity.

At the AAM’s Access! 2026 conference, a dedicated panel on the latest developments for biosimilars discussed challenges and opportunities in the US market, predicting consolidation among current players as well as calling for policies that put biosimilars first.