In this week’s news, EMA looks at similarity, FDA talks generic drug labelling and more…

EMA shares thoughts on manufacturing data and similarity

The EMA has set out its latest expectations for drug quality assessments in a revised reflection paper.

The document – available here explains how statistics should be used in drug development when a comparative assessment of quality attributes needs to be made.

It also analyses potential issues that arise during the development of small molecules and biosimilars and other products for which defining “similarity” is a requirement.

ICH published continuous manufacturing guideline

The International Council for Harmonisation (ICH) has issued its Q13 guideline on continuous manufacturing and asked for feedback from industry.

The ICH said this guideline – which is available here “describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).”

The organisation added that it “provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.”

US generic office sets out its processes for labelling changes

The US FDA’s Office of generic drugs has detailed its internal procedures for handling generic drug labelling changes also setting out the responsibilities of agency staff. The document is available here.

Also in the news

DCAT said the CDMO sector and the wider pharmaceutical industry will face growth challenges over the next few years. Author Jim Miller suggested that although drug sales increased in 2020, growth rates were below historical norms and unit volumes were flat.

The Pink Sheet’s Derek Gingery looked at US FDA efforts to raise the fees drug companies pay the agency. Also Market Watch’s Eleanor Laise looked at the FDA’s wider fee structure.

Zach Brennan from Endpoints reported industry concerns about potential shortages resulting from revised FDA carcinogen testing rules.

The US Department of Justice announced the sale of a one of a kind album by the popular hip hob collective the Wu-Tang Clan to cover the debts of former pharma executive and hedge fund manager Martin Shkreli.

The New York Times liked at the recent FDA approval of Biogen’s Aduhelm.

Bioprocess Insider covered Bluebird Bio’s decision to start selling its gene therapy Zynteglo in the EU.

CDMO trends

Some developments of note in the contracting sector:

Archimica has started work at its expanded multi-purpose active pharmaceutical ingredient (API) manufacturing facility in Lodi, Italy. See press release.

Catalent announced a $100 million expansion program for its facility in Anagni, Italy. The CDMO cited growing demand for biologics services in the EU.

Piramal Pharma Solutions plans to expand its operations in Riverview, Michigan. The move will 31 high-wage jobs according to the Michigan Economic Development Corporation.

Biovac will provide fill-finish and distribution services for Pfizer and Biontech’s COVID-19 vaccine under an agreement announced this week. The contract focuses on supply of the jab in Africa.

Kineta has hired Samsung Biologics to provide end-to-end CDMO service from cell line development, clinical drug substance, and drug product manufacturing services to support IND filing for KVA12.1, Kineta’s novel anti-VISTA antibody in development for the treatment of solid tumours.