BioPharmaceutical

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.

Sandoz’s aflibercept biosimilar Enzeevu launch in Canada comes just a few days after the firm signed a multiple asset deal, including an undisclosed ophthalmology product, with Alvotech, which recently gained immediate launch for its Eylea rival in the country.

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.

Positive results from a randomized study in healthy volunteers mark a key milestone for Alvotech’s proposed Entyvio rivals AVT80 and AVT16.

Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.

A biosimilar collaboration between Kashiv and Saya aims to expand access to affordable supportive oncology therapies in Mexico and 10 additional Central America and Caribbean markets.

Slovenia’s Krka is ramping up capital spending to expand global manufacturing capacity, betting that industrial scale and supply resilience will drive its next phase of growth.

Amgen has revealed just how significant its first-mover advantage on biosimilar aflibercept has been in the US, with the firm’s Eylea rival bringing in sales of $700m in 2025 and helping to push Amgen’s annual biosimilars turnover up by more than a third to $3bn.

The antibody-drug conjugate pipeline has more than doubled to 895 candidates since 2023, with DNA topoisomerase I overtaking HER2 as the dominant target.  

With another settlement secured, US states are gearing up for the first trial of the price-fixing case later this year.

Sun’s founder reinforces the firm’s M&A strategy, indicating that it is "comfortable raising debt" if required, but shares no specific comment on the speculated interest in Organon. The Indian company also has "sufficient supplies" to meet demand for generic semaglutide in India post LoE.

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.