Biosimilars going global but EMA still setting the regulatory pace

By Gareth Macdonald

- Last updated on GMT

Biosimilars going global but EMA still setting the regulatory pace

Related tags Food and drug administration

Biosimilars may be a global business, but the EMA is still setting the pace when it comes to regulations according to UK contractor, BioOutsource.

There have been a number of high profile product launches and filings​ in the past few months which – coupled with several positive predictions​ and forecasts​ about the market – underline growing pharmaceutical industry interest in biosimilars.

However, while Sandoz’s submission in the US​ and Biocon and Mylan’s​ efforts in India may have attracted the attention, the truly global nature of the market is often missed according to Daniel Galbraith, BioOutsource chief scientific officer (CSO).

He told that: “I think we can say with certainty that there is no geographical location worldwide which does not have Biosimilar manufacturers specifically targeting their population.”

Galbraith highlighted Latin America, Taiwan, Thailand, Singapore, India and China as hotspots, explaining that: “There are indigenous pharma companies in all locations, many of them generic small molecule manufacturers who are seeking to move into this market.

“Clearly the Asian countries of India, China and Korea are the key players both domestically and internationally through Asia, Middle East and rest of the world” he added.

Deal or no deal

The level and fluidity of partnering and collaboration – which is something we explored a few weeks ago​ - is also a key feature of the biosimilars sector according to Galbraith.

“The interesting thing is that the [biosimilar] business models are all so variable with each company ploughing their own course and are not frightened to drop partnerships very quickly or have multiple partners for different molecules.”

Support for this idea is seen by the deals that have been announced. For example South Korea’s Celltrion, which filed its first biosimilar with the US FDA in August, has previously established deals with Hospira​, Egis​, Hikma​, Perrigo​, Nippon Kayaku, BioGaran​ (Korean) and Mundipharma​.

Celltrion is followed by Merck & Co, which has biosimilar-related agreements with Hanwa, Samsung Bioepsis, and Fujifilm among others, with Baxter, Samsung Biologics and Actavis next in terms of number of collaborations.


Another interesting feature of the biosimilars market is the regulations that govern it, which vary considerably according to Galbraith.

The EMA is still seen as the most forward thinking agency. They have now approved monoclonal antibodies and seem to be unstoppable with regard to the new guidelines giving manufacturers much more leeway that has been seen in the past.”

This engagement means the EMA’s approach is being copied in other markets Galbraith said, who explained that: “The Korean and Asian markets, especially the Indian market have used the EMA guideline as a blueprint for their own.

“China stands out as having its own unique guidelines that do not dutifully follow the EMA but this may change.”

The elephant in the room, at least when it comes to regulations, is the US according to​ Galbraith, who said: “The big questions is still the US FDA – where they fall re-guidelines is still anyone’s guess but it’s being brought to a head as we speak with the recent submission of an application.”

Related news

Show more

Related products

show more

Process optimization for mAb commercial manufacturing

Process optimization for mAb commercial manufacturing

Content provided by Catalent | 01-Jun-2023 | Product Presentation

Process characterization and validation is an important step in the product development journey and late-phase development, and it is required before transferring...

Related suppliers