Biologics

Roche expects biosimilars to Perjeta and Xolair by the end of 2026, marking a key inflection point for two of its major franchises. Shanghai Henlius Biotech leads development for pertuzumab, while Celltrion is positioned as the frontrunner for omalizumab.

Celltrion is the preferred bidder for the acquisition of a large-scale cGMP biologics manufacturing plant in the US, marking a pivotal move to localize production and secure its US pharmaceutical business against rising tariff risks.

Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.

Despite limited evidence of commercial impact, pharmaceutical companies are making massive strategic investments in AI biologics platforms. The question isn't whether the technology shows promise; it's whether that promise can translate to measurable business results.

Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w

Outlook Therapeutics has started to conquer European markets with its ophthalmic version of bevacizumab. Meanwhile, across the pond in the US, it awaits the FDA’s decision, again.

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.