Manufacturing

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.”

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.

The US FDA aims to prevent poor quality or incomplete responses to Form 483 inspection observations with a new draft guidance that describes the structure and content for concise, factual and effective corrective action responses.

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.

Celltrion will invest KRW1.23trn in two new Songdo plants, adding 180,000L of capacity as part of a broader Korea-US expansion that will lift global drug-substance capacity to 571,000L and support pipeline growth and CMO ambitions.

Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.

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.

Alvotech is shifting toward dual-source manufacturing and operational execution as it addresses FDA setbacks, expands its biosimilar pipeline and drives growth through global launches, with US approvals representing key upside to its 2026 outlook.

Sandoz has unveiled a major reorganization of its generics and biosimilars operations into two distinct businesses, bringing in Ferring and Merck veteran Armin Metzger to lead a new global biosimilars unit while at the same time assigning existing executives to generics roles.

Generics Bulletin editor Dave Wallace joins Pink Sheet editors to discuss the generics and biosimilars industries’ priorities following the recent AAM Access! 2026 conference, as well as FDA Commissioner Martin Makary’s interesting take on the compassionate use program.

Sandoz enjoyed good sales and profit growth in 2025, with a significant increase in free cash flow allowing the firm to continue investing in its major European biosimilars manufacturing network.

Centrient has urged the EU to strengthen its supply chain resilience, including incentivizing local manufacturing through revised procurement practices, after India took action to protect its antibiotics market from an increasing Chinese monopoly.

European Commission authorization clears the way for regional launches, as the newly opened golimumab biosimilars segment begins to take shape.

As India implements minimum import prices for certain antibiotics and key starting materials, Sandoz's Simon Goeller speaks to Generics Bulletin about the potential for Chinese suppliers to dominate the world market and weaponize supply.

Phlow and Fresenius Kabi are partnering in the US to establish a fully domestic manufacturing pathway for epinephrine injection, with launch targeted for 2027 pending approvals. The collaboration is aimed at addressing the current lack of a US-based API producer.

The FDA wants to waive facility fees for three years if a sponsor breaks ground on a US-based manufacturing plant, but industry is concerned the idea will force other sponsors to subsidize competition.

After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.

MS Pharma is continuing to capitalize on opportunities for localized manufacturing in the Middle East, with its latest deal with Hetero Biopharma covering five biosimilars.

Lanreotide supply issues cloud Cipla’s Q3 FY26 earnings, with impact seen in Q4 as well, though pipeline assets augur well for US growth continuity. Perpetual rights to Novartis’s Galvus effective Jan 1, seen adding momentum to India diabetes gains.

As Dr Reddy’s delivered results for its financial third quarter, the firm revealed a slew of updates for key biosimilars in its pipeline including filing and launch plans for abatacept in the US and Europe, as well as US setbacks on rituximab and denosumab.