Biosimilars

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.

Industry slams FDA draft guidance on biosimilarity

Industry slams FDA draft guidance on biosimilarity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Industry groups BIO and PhRMA, as well as biotech company Genentech, are taking issue with US FDA draft guidance that is designed to help companies design and use clinical pharmacology studies to help prove that a developing biosimilar is similar to its...

Institutional investors decry US battle over biosimilars

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.

Cipla acquires mAb manufacturer Mabpharm

Cipla acquires mAb manufacturer Mabpharm

By Zachary Brennan

Indian biopharma Cipla is pushing further into the realm of monoclonal antibody manufacturing with its purchase of India-based Mabpharm.

GPhA, retirees and pharmacies call for same INNs for biosimilars

GPhA, retirees and pharmacies call for same INNs for biosimilars

By Zachary Brennan

The fight over how biosimilars should be named in the US just got more tense as a group of pharmacists, pension systems and the Generic Pharmaceutical Association are calling for a system similar to what’s used in the EU, with the same INNs (international...

EU green lights first insulin biosimilar from Lilly, BI

EU green lights first insulin biosimilar from Lilly, BI

By Zachary Brennan

The EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended granting a marketing authorisation to Boehringer Ingelheim and Eli Lilly’s biosimilar insulin treatment for Type 1 and Type 2 diabetes patients.

US FDA unveils long-awaited biosimilar guidance

US FDA unveils long-awaited biosimilar guidance

By Zachary Brennan

The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.