Scared to Jump on the Biosimilars Bandwagon? You’re Not Alone

As of March of this year, only 17 biosimilars had been approved for sale in the US by the FDA. Of these, only one has been commercially successful. Yet we know that biosimilars do very well in Canadian and European markets. It’s well publicized that in 2020, $100 billion worth of biologics will be off-patent and ready for biosimilar development. But with such a low approval and adoption rate in our market, many companies may remain on the fence. What are the barriers to biosimilar adoption in the US, and how can we overcome them?

FDA & Legal Processes: The patent challenge timeline remains an issue for many potential biosimilar manufacturers. While it is now possible to enter a patent challenge up to eight years before a product launch, per the Biologics Price Competition and Innovation Act, the lengthy process can be a turn off for many companies, as there is little proof of market acceptance up to now. In many cases, the legal cases for determining a patent challenge have stretched far beyond the FDA’s approval time for the biosimilar. 

Additionally, with so few biosimilars on the market, it can be a challenge to find professionals trained in regulatory compliance for biosimilars. The drug development process can be another discouraging risk for companies. After years of legal maneuvering, to have a biosimilar trial fail for faulty regulatory compliance would represent possible millions in sunk cost, and many more millions in potential lost revenue. 

Education & Marketing Barriers: Many existing biologics have benefitted from excellent marketing campaigns that have educated consumers on the effectiveness of the patented, brand name drug, and lengthy physician training sessions to convince them to prescribe the drug. Most biosimilars will not have the budget for flagship treatment, no matter the potential success and earning potential. Moreover, the adoption of biosimilars in foreign markets is due in large part to government agencies educating physicians on the safety and efficacy of biosimilars. So far, this training is few and far between in the US. In order for biosimilars to be a success in the next decade and beyond, companies should invest in messaging to the public and practicing doctors.

CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars is essential for pharmaceutical professionals who are producing biosimilars, or companies who are looking to set up drug discovery and development testing. Regulatory compliance training eases the path of development for biosimilars and can ensure the success of your compounds and biologics.