Topics:

Boehringer blueprints new division to tackle biosimilar development

Tools

Following the well-worn path taken by Merck and some noted global conglomerates, the pharma giant Boehringer Ingelheim is setting up a division aimed at developing biosimilars.

Boehringer director Wolfram Carius told InPharm that the pharma company already has the technology needed to be successful here. "We feel confident that we are able to leverage our capabilities in product development, supply and clinical expertise at Boehringer Ingelheim to offer high quality biosimilars understanding patients' needs," Carius remarked.

There's a growing number of players committing themselves to the biosimilar game. Europe already has a regulator system in place to cater to the developers of follow-on therapies, which are expected to offer generic biologics at somewhat reduced prices. The FDA has been slower to act than the Europeans, but recently Janet Woodcock indicated that the agency would have its regulatory pathway for follow-ons ready for public consumption in a matter of days or weeks.

Merck has been one of the most active Big Pharma companies to set up biosimilar programs. It's Merck BioVentures operation has been buying up technologies and doing deals with the likes of Hanwha Chemical in South Korea. Pfizer also has been at work, striking a significant biosimilar pact with India's Biocon last fall.

Noticeably absent amid all the activity, though, are the smaller biotech companies. The FDA expects to see significant animal and human data for new biosimilars, making this an expensive field to compete in.

- here's the story from InPharm

Related Articles:
Report: FDA readies release of long-awaited rules on biosimilars
FDA sketches a complex instruction manual for biosimilars
FDA outlines steep hurdles, early fees for first-gen biosimilars