Biologics

Regeneron says it is closely watching Amgen’s Pavblu 2mg aflibercept biosimilar, which is gaining traction via financial incentives to physicians as “the only differentiator” to its Eylea reference brand. Meanwhile, Regeneron is aiming to boost Eylea HD uptake amid regulatory setbacks.

Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Brazil’s drug regulator has published a new technical note updating guidelines on registration and post-registration procedures for biological products.

China implements a new pilot scheme allowing non-end-to-end manufacturing of certain biologics before possible nationwide implementation for all such products, with resource optimization and aligned quality management systems among the main goals.

CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.

Axcynsis is developing a derivative of the chemotherapy agent Yondelis as a new payload, which the Singapore venture will first apply to a Claudin 6-targeting ADC it plans to take into a Phase I trial in the US, its chairman, CEO and founder tells Scrip in an interview.

ProBiotix Health has announced two commercial partnerships for the distribution of its probiotic ingredients, with Deutsch-Pharm in Ukraine and Eifron in Greece respectively.

Syngene’s CEO talks to Scrip about how the firm is deepening capabilities in areas like ADCs, PROTACs and why the US Inflation Reduction Act may not necessarily shrink outsourced small molecule work. The executive also shares his view on the China ‘rebalancing’ trend amid geopolitical tensions and the US BIOSECURE Act.

The Belgian drugmaker’s dual IL-17A and IL-17F inhibitor is now approved for four indications in the US, with another in hidradenitis suppurativa expected soon, and analysts believe that UCB’s peak sales forecast of €4bn could be on the conservative side.

Rare disease activities within the biologics center will gain more prominence with a senior official overseeing them.

Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.