Today is a time of growth and change for the generic pharmaceutical sector.
The global generics market reached $269.8 billion in 2012 and is expected to reach $518.5 billion by 2018, with a compound annual growth rate (CAGR) of 11.5%.
The generic drug industry covers the marketing and sale of medication containing the same active ingredients (APIs) and dosages as brand-name drugs manufactured by the pharma industry. Generic drugs are under the same governance as brand-name drugs and must adhere to the same standards. When brand-name drugs come off patent, the market is opened up to generic versions.
According to a 2014 report from BCC Research, major aspects that combine to create an opportunity for sites to consider expanding into studies of generics include:
When entering the generic landscape, it is important for sites to acquire self-identification with the FDA’s electronic submission gateway as a transaction partner to perform clinical trials. This is known as GDUFA, the Generic Drug User Fee Amendment. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and reduce cost to the industry. GDUFA, signed into law in July 2012, is based on an agreement negotiated by the FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. GDUFA self-identification is required by some sponsors to participate in generic studies.
The following types of generic industry facilities, sites and organizations are required to self-identify with the FDA:
- A site at which a bioanalytical study is conducted,
- A clinical research organization,
- A contract analytical testing site, and/or
- A contract repackager site.
In many case, failure of a site or organization referred to in an ANDA to self-identify can result in a delay in review or approval of that ANDA. The failure of a site or organization to comply with the law and self-identify may raise significant concerns about that site and could increase the likelihood of a site inspection prior to approval. The FDA does not give priority to completing inspections required simply because sites fail to comply with the law requiring self-identification.
For instructions on electronic self-identification of generic drug facilities, sites and organizations, visit: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm320400.htm
Other factors influencing the decision to consider generics as a revenue stream for sites:
Expansion into generics may be a good choice for some sites. While it is worth noting the self-identification process can be arduous and lengthy, it also is notable that the effort may be worth the opportunity.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas.
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