Achieving consistent regulation for biosimilars Posted 26/07/2019

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

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