In this week’s news, FDA gives advice on bispecific mAbs, industry tries to ramp up Covid-19 vaccine output and more…

Bispecific antibody regulations introduce new manufacturing requirements

CDMOs and drug companies making bispecific antibodies face some additional regulatory hurdles in new final guidelines issued by the US FDA.

The document – available here states that although the pathway for the evaluation of monoclonal antibodies is established, firms making antibodies that target more than one antigen needed additional guidance.

One piece of additional guidance is that the FDA may ask to compare a bispecific antibody to an approved monospecific product directed against the same antigenic target to “inform the benefit-risk assessment of the bispecific antibody.”

To date only three bispecific antibodies have been approved in the US – Janssen’s Rybrevant (Amivantamab-vmjw), Amgen’s Blincyto (blinatumomab) and Roche’s Hemlibra (emicizumab-kxwh) – although according to the FDA around 100 are in development.

Specific guidelines for complex generics

In other FDA news the agency has published a list of upcoming guidance documents it is developing for complex generic products.

The regulator publishes guidelines – known as product specific guidelines on a quarterly and as needed basis.

The next batch will include advice for firms making asthma medicines, treatments for Parkinson’s disease and hormone replacement therapies.

Also in the news

Inside Health Policy reported US FDA plans to set up an inspections council tasked with optimizing inspections and updating data infrastructure. The aim is to facilitate consistent use of inspection tools and tech and provide additional flexibility for the use of data-driven, risk-based oversight modelling says the agency.

DCAT examined the EU API market and global supply chain in light of the EC decision to update the region’s Industrial strategy. The focus on environmental concerns and the expanding digital economy will result in significant changes for API suppliers and CDMOs DCAT says.

DCAT also took a look at growing biopharmaceutical industry use of continuous manufacturing.

The Irish Times reported that Pfizer is going to start making its Covid-19 vaccine in Ireland before the end of the year.

The Medicine Maker looked at how Covid-19 has impacted the entire pharmaceutical industry in the past year. From initial delays and disruption though to efforts to add capacity, the pandemic has had a profound and lasting impact according to the author.

Politico reported vaccine sector efforts to increase Covid-19 jab production.

Reuters reported that the EU is planning to take AstraZeneca to court for breach of contract in relation of Covid-19 vaccine supplies.

CDMO trends

Some developments of note in the contracting sector:

Thermo Fisher Scientific has formed a strategic alliance with University of California, San Francisco (UCSF) to accelerate the development and manufacturing of cell-based therapies.

Astex Pharmaceuticals has hired Recro Pharma to help develop and manufacture an undisclosed cancer medication.

CRO Charles River Labs will buy CDMO Vigene to expand its gene therapy manufacturing capabilities.

Newly formed contractor Resilience says CDMOs need to invest in innovation to cater for growing demand for the production of complex medicines.

Becton Dickinson and Co will build a €165 million ($200 million USD) manufacturing facility for prefilled medicines in Zaragoza, Spain.