Generics Bulletin

New US tariffs of up to 100% on patented drugs have spared generics and biosimilars for now, highlighting their role in supply chains, but officials have ordered a review of the sector within one year.

In the second part of Generics Bulletin’s interview with Keren Haruvi, the Sandoz executive talks about her role as outgoing chair of the US Association for Accessible Medicines, and the achievements made by the group since it came under new leadership.

Hyloris has received a CRL from the US FDA for its valacyclovir oral liquid due to manufacturing issues at its CDMO, with no concerns on the product itself, and warns resolution could delay approval into 2027 as it explores alternative production options.

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.

The latest off-patent industry appointments have seen Jeff Watson return as president and CEO of Apotex and Pamela Hoffman take the title of CEO of Padagis, while Australia’s GBMA and Medicines for Ireland have announced new leadership.

Teva has confirmed no operational impact after a missile-related incident near its Neot Hovav site, countering reports that raised concerns over supply chain risk and manufacturing resilience amid escalating regional tensions.

Amarin is asking the US Supreme Court to uphold the Federal Circuit in its Hikma dispute, arguing that skinny-label carve-outs do not shield generics from inducement liability when broader marketing conduct encourages patented uses.

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.

Generics Bulletin reviews global regulatory developments across the world.

Teva marked a three-milestone celebration in its biosimilar portfolio – an approval and dual filing acceptance – as the firm advances its Pivot to Growth strategy.

Generics Bulletin previews the most noteworthy and anticipated events for April 2026.

Marking the latest definite step towards a streamlined regulatory pathway for biosimilars as standard, the EMA has formally adopted its reflection paper on a tailored clinical approach in biosimilar development.

CapVest has completed its deal to take majority ownership of Stada, promising to inject fresh capital into the company to pursue both organic growth and strategic acquisitions.

The AAM has become the latest generics and biosimilars industry body to warn of potential supply-chain threats as the war in Iran and the Middle East continues, suggesting that a prolonged conflict could raise the risk of shortages as suppliers are “starting to experience more challenges.”

Viatris is accelerating its shift to higher-margin, value-added medicines, combining near-term launches, cost restructuring and disciplined dealmaking to drive sustained growth through 2030, while leveraging a stable generics base and advancing a late-stage innovative pipeline.

Announcing itself with a multi-product biosimilar deal, newly-unveiled biotech firm Neion Bio is planning to revolutionize the market with a proprietary technology platform that uses genetic engineering tools to manufacture recombinant biologics in eggs.

Outlook Therapeutics has raised $23m through debt and equity financings as it continues to grapple with repeated FDA setbacks for its ophthalmic bevacizumab candidate, leaving its US approval pathway uncertain despite growing traction in Europe.

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.

Henlius and its commercial partner Organon have ticked off another market for their denosumab biosimilar pair.

Keren Haruvi, head of Sandoz in North America, discusses the firm’s ambitions to become the number one biosimilars supplier in the US – and at the same time, explains why the US generics market is “not attractive enough to heavily invest to grow.”