The health care reform in the United States has been one of the main projects of the U.S government in recent years and is beginning to bear fruits. The Patient Protection and Affordable Care Act, signed on March, 23rd 2010, defines the legislative framework for the development of biologic drugs. However, some major questions remained unanswered, and health care related industries were impatient to have more formal guidelines. Finally, the FDA issued three guidance documents on February, 9th 2012, to assist industry players in developing biosimilars in the United States.
The proposed rules require drug development companies to provide studies revealing that the generic copies are “highly similar” to the originals, and prove it using one of several methods described by the FDA.
Before making the guideline definite and permanent the FDA has set a period of 60 days during which it is welcoming feedback and comments from the industry on the following topics:
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: this section intends to assist companies by providing them some scientific stepwise approaches that aims to show the similarity between the biosimilars and the reference product.
- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product: provides an overview of analytical data to consider when assessing biosimilarity between a proposed therapeutic product and a reference product.
- Biosimilars: Q&A Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: provides answers to the common questions from manufacturers on developing biosimilar products.
The FDA itself gives leeway for case by case assessments of each proposed biosimilars along their respective development paths. These guidelines will nevertheless support companies in developing new drugs that are in accordance with FDA approval processing, thus helping them saving money. By giving way to companies to make feedback and get involved in the guidelines, the FDA intends to release a framework that is both safe for patients and open enough to let the companies innovate.
The rising of biosimilars is a real challenge for the pharmaceutical industries. The worldwide market for copies of biotech medicines is expected to grow to $3.7 billion by 2015, from just $243 million in 2010! Lots of makers of biotech drugs makers have already anticipated the growth of this market and working to produce rival versions of biotech drugs made by competitors.
The development of biosimilars will not only benefit the industries but also the Federal government. Indeed, The Congressional Budget Office has estimated that the United States could save $25 billion from the use of biosimilars over 10 years.
If these guidelines hardly surprised the key accounts of this sector and are close enough to the guidelines of the European Medicines Agency (EMA), they are generally considered more favourable to this industrial sector that is facing some changes.
Read the full article in French (Author : Lisa Treglia, Deputy Scientific Attachée Consulate General of France in Boston)