Biosimilars

The comments might just be the tip of the iceberg

Amgen, Pfizer weigh in on EMA draft guideline on biosimilars

By Zachary Brennan

Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.

Will this be the first of many biosimilars to hit the Indian market?

Ranbaxy launches India’s first Remicade biosimilar

By Zachary Brennan

Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.  

Merck Serono pledges €150m to biosimilars in 2015

Merck Serono pledges €150m to biosimilars in 2015

By Zachary Brennan

Merck Serono is planning to invest between €130m ($168m) and €150m ($194m) in biosimilars in 2015, depending on the outcome of ongoing Phase I studies, the company announced Thursday.

Bright eyes was OK at best

infographic feature

Better together? biosimilars sector says aye

By Gareth Macdonald and Dan Stanton

Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.

Pfenex set for new direction as it uses its expression technology to develop its biosimilar pipeline

Pfenex focuses on biosimilars post IPO

By Dan Stanton

Revenues from protein production will decline as Pfenex shifts attention to its biosimilar pipeline, the newly public company says.

BIO, PhRMA and Genentech all take particular issue with the FDA’s four possible outcomes for the analytical comparison of a proposed biosimilar product with its reference product

Industry slams FDA draft guidance on biosimilarity

By Zachary Brennan

Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...

The investors claim that the information surrounding the biosimilar market in the US is imbalanced.

Institutional investors decry US battle over biosimilars

By Zachary Brennan

As Celltrion announced Monday that it filed the first monoclonal antibody for approval with the US FDA, investor groups are crying foul over some of the tactics used by others in industry to discourage the uptake of biosimilars in the US.