In this week’s news, GMP requirements for advanced therapies rejigged, US push for biosimilars and more…

EMA clarifies on GMP for advanced therapy starting materials

The EMA has issued a Q&A outlining “minimal” GMP requirements for drug firms and CDMOs that make advanced therapies. The document focuses on good manufacturing practices (GMP) that should be applied to starting materials for advanced therapy medicinal products (ATMPs) of biological origin.

The core message is that while GMP certificates are not required for manufacturing and testing sites of starting materials for ATMPS the standards should be followed. It wrote “For certain starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs it is, however, mandatory that the principles of GMP are complied with.” The Q&A document recommends that, If starting materials are procured from different manufacturers, a requirement for “appropriate principles of GMP” should be included in the supply contract.

PIC/S details GMP updates

In related news, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has updated its GMP guide for advanced therapy medicinal products (ATMPs). The update – detailed here and here – cover cell and gene therapy products and active substances, respectively.

US FDA mandated to educate doctors on biosimilars

A new US law has been introduced setting out how doctors should be educated about biosimilars. The law – here – compels the Food and Drug Administration (FDA) to advance education and awareness among health care providers about biological products as appropriate, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars.

Industry groups welcomed the move. Christine Simmon, Executive Director of the Biosimilars Council, said, “Education is a crucial step toward more widespread adoption of safe, effective and more-affordable biosimilar therapies.

She added, “There is much work to be done in the United States to increase usage of biosimilars, stimulate competition and reduce prices for patients.”

Also in the news

US politicians have introduced legislation they say will let the government negotiate the cost of prescription drugs more effectively.

STAT reported that US President Joe Biden has spoken with 3M, AmerisourceBergen, PhRMA, and others about shoring up the national stockpile.

Endpoints looked at US FDA remote facility evaluations and concluded they will not help the agency reduce its backlog.

Australia’s Victoria state government has announced plans to build a mRNA vaccine production facility.

Politico covered continued US support for J&J’s Covid-19 vaccine amid problems at its CDMO.

Bristol Myers-Squibb has selected Leiden, the Netherlands to house a new cell therapy manufacturing site.

CDMO trends

Some developments of note in the contracting sector:

Sharp plans expand operations at facilities in Allentown and Conshohocken and add a third facility in Macungie Borough, Lehigh County, Pennsylvania over the next three years.

Lonza is building a new small molecule manufacturing complex at its site in Visp, Switzerland.

Evotec has started construction of a biologics facility in Toulouse, France. It will employ small, automated, highly intensified and continuous bioprocessing technologies inside autonomous cleanrooms.

Aceto has bought A&C, a manufacturer of specialty excipients, buffers, and process solutions.

Nanoform Finland and Aprecia are “exploring the synergies between their respective technologies in the field of nanoparticle-enabled 3DP dosage forms.” See press release.