Research & DevelopmentBiologics & Biosimilars

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

In 2010, Congress approved the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars, while maintaining incentives for continued medical advances. To achieve the balance between increased competition among biologics from biosimilar products with the need for incentives to support future medical innovations, Congress provided biopharmaceutical innovators with 12 years of data protection for biologic medicines. To date, the FDA has issued several draft and final guidance documents to assist biosimilar sponsors in generating data to support biosimilar applications. FDA guidance and regulations provide insight into the agency’s current thinking regarding how it will evaluate biosimilar biological products. The FDA approved in March 2015, the first biosimilar product for marketing in the United States.

What is a Biosimilar?

A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine already approved by the U.S. Food and Drug Administration (FDA). Under U.S. law, a biosimilar is approved based on demonstrating that it is “highly similar” to an existing FDA-approved biological product, known as a reference product.  

Biosimilars are highly similar to the reference product that they are compared to in terms of safety, purity, and potency, but have allowable minor differences in clinically inactive components because they are made from living organisms. In approving biosimilars, the FDA requires that manufacturers conduct a clinical trial to ensure there are not any clinically meaningful differences in terms of safety and effectiveness from the reference product. 

Increasing Competition Among Biologics and Biosimilars

In 2010, Congress approved the Biologics Price Competition and Innovation Act (BPCIA), creating an abbreviated approval pathway for biosimilars, while maintaining incentives for continued medical advances. To support innovation and competition in the marketplace, Congress provided 12 years of data protection for innovative biologic medicines. This framework provides a balance between providing incentives for development of innovator biologics and spurring the introduction of and access to biosimilars.To date, the FDA has issued several draft and final guidance documents to assist biosimilar sponsors in generating data to support biosimilar applications. FDA guidance and regulations provide insight into the agency’s current thinking regarding how it will evaluate biosimilar biological products. The FDA approved the first biosimilar product for marketing in the United States in March 2015. The FDA is working to provide additional guidance on how biosimilar products could become interchangeable or not be considered interchangeable to reference products. In 2018, FDA Commissioner Gottlieb introduced the Biosimilars Action Plan to help spur competition and innovation for biosimilars. As of Jan 2019, 16 biosimilars have been approved in the U.S.1

As the market and experience with biosimilars increases, we expect usage to play an expanded role in treatment options for patients and decrease prescription drug spending. Myvideopays commends the FDA for its efforts to enhance competition and encourage innovation in the biologics market and looks forward to continuing to work with the FDA on science-based regulations that ensure patient safety.

 

1

 

                              

 

Related Resources

www.medicaments-24.net

prix viagra

Acheter Cialis 40 mg