The US Food and Drug Administration is getting ready to review generic biotech drugs for the first time.
In advance of this, it released on 10 February 2012 guidelines under which the review process will be carried out. For consumers, the move represents the chance to obtain these hi-tech drugs - which presently command high prices - much more cheaply as so-called ‘biosimilars'.
The 2010 Patient Protection and Affordable Care Act featured one section calling for a biosimilar drug approval channel to open up but stated the FDA should be responsible for its content.
Draft Biotech Drug Guidelines
The draft biotech drug approval guidelines now release represent the administration's response to this call and they cover several areas. These include ‘Scientific Considerations', which supplies information to help generic biotech drug manufacturers prove that their products resemble those on which they're based. Also focused on are ‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product'.
"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process", Janet Woodcock from the administration's Center for Drug Evaluation and Research explained in a statement. She added: "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Generic Biotech Drug Approval
Responding to the news of these generic biotech drug approval guidelines' release, manufacturers expressed content and a statement issued by GPhA - the Generic Pharmaceutical Association sums up their feelings.
"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients", the organisation said.
According to IMS Health, the worldwide biosimilars market has the potential to reach $25bn in value by 2020, thereby occupying a 10 per cent share of the overall biotech drugs market.
From here, the FDA's guidelines will be open for 60 days consultation, then firmed-up before being re-released in final form.
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