In this week’s news, FDA updates guidelines for biosimilar drug manufacturers, sets up new digital office and more…

US FDA tweaks biosimilar Q&A document for industry

The US FDA has issued another Q&A document for drug firms and CDMOs making biosimilar products.

The document – available here – includes several new questions relating to how manufacturers can show their biosimilars are the same strength as the reference product.

There are also new questions addressing paediatric assessments and – of particular relevance for CDMOs the information is needed to support post-approval manufacturing changes.

US FDA sets up digital transformation office

The FDA has reorganized its information technology (IT), data management and cybersecurity functions into the new Office of Digital Transformation (ODT).

The agency said the move will allow for more effective and efficient data and IT management and help it reduce duplicate processes and use shared services within agency offices and centres.

Acting FDA Commissioner Janet Woodcock said “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products.”

ICH quality guides taken on by most members

Most ICH members have adopted the organisation’s drug quality, safety and efficacy guidelines according to a new survey.

The survey quizzed organisations like Brazil’s ANVISA, China’s National Medical Products Administration (NMPA), Singapore’s Health Sciences Authority (HSA), South Korea’s Ministry for Food and Drug Safety (MFDS) and Taiwan’s FDA and 30 drug firms about the guidelines.

According to the author respondents showed “there was generally a strong level of adherence based on agency self-declaration and company perception.”

However, it also revealed that some guidelines are being adopted more slowly than others, with the S5(R3) guideline on reproductive toxicity yet to be widely embraced.

Also in the news

Many CDMOs making OTC products missed the deadline for paying their facility fees according to analysis by Lachman Consultants.

The New York Times took a look at technology advances in the biotechnology sector.

Pfizer initially turned down the offer of developing a coronavirus vaccine because its executives thought the virus would be rapidly contained according to the Telegraph.

The Irish Independent looked at J&J submission of a planning application for a €150M expansion of its Co. Cork plant that could create around 180 jobs.

STAT’s Pharmalot examined US politicians’ concerns the US patent system is resulting in higher drug prices.

CDMO trends

Some developments of note in the contracting sector:

Thermo Fisher Scientific will invest $154 million to expand its pharmaceutical manufacturing operations in Greenville, North Carolina. See press release.

PII has acquired new filing technology to cater for the needs of customers for which it makes vaccines.

Catalent has signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company that develops treatments for gastrointestinal diseases.

NeuExcell Therapeutics has hired FUJIFILM Diosynth Biotechnologies to make NXL-001, a potential neuro-regeneration gene therapy to treat ischemic cortical stroke. See press release.

AGC Biologics plans to expand its Heidelberg facility to increase manufacturing capacities for plasmid-DNA and messenger RNA projects.