Canadian regulators forging new biosimilar pathway

While U.S. lawmakers jawbone about a regulatory pathway for biosimilars, or biogenerics, Canada has moved to do it. Health Canada has posted draft guidelines for its regulatory approach to biosimilars. Manufacturers would have to show their products were similar to an existing biologic with interchangeability and substitutability decided on a case-by-case basis. New guidances are being drafted for various product classes.

In the U.S., meanwhile, there have been growing signs that any new legislation on biosimilars could be delayed past the current election year. But in Europe, regulators are busily approving a new slate of follow-on therapeutics.

- check out the report from FDA News
read the article on the EMEA's approvals in Motley Fool

Suggested Articles

Bluebird Bio offered the first glimpse of how its CAR-T follow-up is working in multiple myeloma patients who have tried several other treatments.

Zentalis is coming out of stealth with an $85 million series C, which will propel its lead programs into pivotal trials and broaden its pipeline.

The planned takeover centers on ARQ 531, a BTK inhibitor that triggered durable responses in patients with B-cell malignancies.