Biologics

In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry. 

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

While 2024 has seen two buyouts of antibody-drug conjugate specialists with $1bn-plus price tags, the focus on ADCs has continued, accounting for almost half of recent oncology deals.

While Korean biopharma companies’ out-licensing deals have remained lackluster in the past couple of years, activity around emerging modalities, led by ADCs, have been increasing in line with global trends.

In this week's podcast edition of Five Must-Know Things: Merck & Co. steps into CD19 bispecific space; gene therapy patients rise, but slowly; Madrigal’s Rezdiffra plans; Korean biopharma financing recovering?; and approvals to watch out for in Q3.

The US FDA’s regenerative medicine advanced therapy designation is seeing its biggest year yet after a slower ramp-up than the more established breakthrough therapy pathway.

The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

The FDA’s experience with product-specific guidances for generic drugs may impact biosimilar industry decision-making, but the program has improved in recent years.

Lytenava, Outlook Therapeutics’ ophthalmic version of bevacizumab for wet AMD, has been given the INN bevacizumab gamma, but it is not a new active substance, the EU authorities have confirmed.

After announcing a pivot to innovative oncology treatments from biosimilars, Coherus has granted an exclusive license for its novel biologic cancer therapy Loqtorzi to Apotex in Canada.

UK prebiotic specialist Clasado Biociences is expanding across APAC and Eastern Europe through two recently-signed distribution deals: Alliance Nutrition Group’s Shanghai Prochin for China and BART in Poland.

Globally harmonized guidance on evaluating the viral safety of biotechnology products has undergone major revisions for the first time in over two decades to address a raft of scientific advances. Manjula Aysola explores the changes and their impact for manufacturers.

Almost a year after launching Celltrion’s Yuflyma rival to Humira in the US, Tom Nusbickel, chief commercial officer of Celltrion USA, reflects on experiences in the market so far and key launches on the horizon, in an exclusive interview with Generics Bulletin.

Sun’s CEO (North America) Abhay Gandhi tells Scrip how not many gave the firm a chance in the US with Ilumya, now with global sales of over half a billion dollars, and outlines prospects of deuruxolitinib for alopecia areata. India’s top-ranked drug maker also has an eye on China R&D assets.

The Dr. Reddy subsidiary CRDMO Aurigene has opened a new biologics facility in India, with plans to finish the plant’s manufacturing capabilities later this year.

New regulation on  substances of human origin (SoHO) will help improve Europe’s “strategic autonomy” and improve access to such substances, say industry representative.

The biotech presented preliminary data on chronic hepatitis D from the Phase II SOLSTICE study of tobevibart and elebsiran at the EASL meeting.

Outlook Therapeutics has revealed more details of its European launch strategy for its Lytenava ophthalmic bevacizumab following the product’s formal European Commission approval.

Sanofi and Regeneron could have the first biologic on the market for COPD – and a potentially better one is in the works.