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Sollers is a graduate school located in New Jersey, specializing in clinical research, drug safety and pharmacovigilance training.

Our graduate certificate and masters programs cover a wide range of subjects tailored to this fast growing industry, and our graduates go on to highly successful careers in the pharmaceuticals industry and healthcare industries.

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What Are The Biggest Biosimilar Challenges?

Posted by Phil on Nov 1, 2016 12:19:46 PM

The term biosimilar refers to a pharmaceutical drug that is similar to an originally approved biological product with significant differences in safety and active properties. It is not surprising that a lot of pharmaceutical companies are showing a keen interest in developing biosimilar products. Thus, there are a few biggest biosimilar challenges that need to be tackled very quickly. They are as follows:

Need for Detailed and Precise Regulations Globally

Biosimilar developments have already started and pushed for approvals in every country. United States came up with Biologics Price Competition and Innovation Act in 2010 to help FDA in drafting legal guidelines based on this framework in 2012. FDA took another three years to come up with final draft documents in 2015 defining guidelines and standards for approval for biosimilar products.


European Medicines Agency (EMA) was the first organization to define guidelines in 2005 for approval of biosimilars on the basis of quality, safety, and effectiveness. These guidelines were further updated in 2013 to include clinical, nonclinical and quality issues. World Health Organizations (WHO) had already released its set of guidelines in 2009 regarding acceptance of biosimilar products. However, other countries still do not have their own guidelines and use the combination of guidelines defined in US and Europe as standards.

Development to Carry Out Trials

A major requirement for any biosimilar to be approved is to have a strong backup of clinical trials including efficacy/safety and sequential PK/PD trials. Immunogenicity profiling is another important parameter that needs to be analyzed with comprehensive clinical trials. Thus, there is a need for developing facilities for carrying out trials.

Conclusion: As patents worth more than $67 billion set to expire by the end of 2020, there is a great acceleration in the process of developing biosimilar. As companies are pushing for approvals, countries all around the world need to have a global framework with clear guidelines for biosimilars. Companies need to find facilities to carry out clinical trials of biosimilars quickly.

image source: apsconsulting 

Topics: Drug Safety