Achieving consistent regulation for biosimilars

Home/Reports | Posted 26/07/2019 post-comment0 Post your comment

Although biosimilars offer the similar clinical outcome as their reference counterparts at a lower price, this is yet to be fully recognised in the US.  Regulatory consistency is essential to achieving a successful biosimilars market in the US, according to Dr Gillian Woolett of healthcare consultancy Avalere Health, who gave a presentation focused around the biosimilars market in the US at the 17th Biosimilar Medicines Conference in The Netherlands.


The latter half of her presentation focused on regulatory issues, particularly the need for consistent application of regulatory principles for biological drugs. She said there needs to be more awareness that all biological drugs vary – whether they are reference product or biosimilar – in order for biosimilars to succeed in the US.

She also discussed the role of manufacturing, explaining that manufacturing processes should be made more efficient in order to make biosimilar drugs more affordable, and therefore more accessible. Although biological drugs are more complex to produce than small molecules, the manufacturing challenges are the same for each drug and should be shared by biological sponsors.

Similarly, when testing biosimilar drugs, there is no need for repetitive and unnecessary clinical studies, which increase prices for consumers. Dr Woolett emphasised that all clinical studies are a tax on patients, and therefore repetitive studies that use the same materials and do not provide new data must be minimised.

Figure 2: Excessive studies conducted for a range of biological drugs
Biological Trade name Sponsor Countries in which first approvals were based on the same studies Studies submitted for 1st approvals in > 1 country Indications studied
 Infliximab Remicade Janssen US, EU, Canada, Australia T16, T21 Crohn’s disease
Etanercept Enbrel Amgen US, EU, Canada, Australia 16.009, 16.014 Rheumatoid arthritis
Adalimumab Humira AbbVie US, EU, Canada, Australia DE009, DE011, DE019, DE031 Rheumatoid arthritis
Pegfilgrastim Neulasta Amgen US, EU, Canada, Australia 980226, 990749 Febrile neutropenia in treatment of non-myeloid cancers
Bevacizuma Avastin Genentech/Roche US, EU, Canada, Australia AVF2107g, AVF0780g

Metastatic colon cancer


Ranibizumab Lucentis Genentech US, EU, Canada, Australia FVF 2598g, FVF2587g, FVF3192g Age-related macular degeneration

This is not necessarily a comprehensive list of the countries in which these studies were submitted for licensure of the product.

Webster CW, Woollett GR. A ‘global reference’ comparator for biosimilar development. BioDrugs. 2017;31(4):279-86.

It is also important to achieve harmonisation and regulatory convergence, as this will allow larger datasets to be collected and more quickly. Example initiatives include the Drug Quality and Security Act (DQSA) which was introduced in the US in 2013 and outlines plans to build an electronic system to identify and trace prescription drugs. Similarly, the EU has introduced the use of a unique identifying 2D barcode for the authentication of medicinal products.

Initiatives such as these are paving the way for worldwide standards, but there is a need for more coordinated studies that provide data upon which actions can be taken in multiple jurisdictions, said Dr Woolett.

Ultimately, robust and consistent regulation will build consumer confidence in biosimilar medicines. Although very high regulatory standards can make prices unaffordable, low standards are unacceptable, and so data must be leveraged to the right standard, in a way that minimises unnecessary repetition of studies.

Dr Woolett concluded that trust in regulatory authorities and the basis of their decisions is critical. This, combined with more competition, will generate innovation in the biosimilars market, leading to increased patient access.

Related articles
Challenges facing the US biosimilars market

FDA issues guidance on quality-related considerations for biosimilars

Economic considerations for biosimilars in the US

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010