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:

• The demand for generics is increasing steadily because of pressure to control healthcare costs.

• A major growth driver for the generics sector is the phenomenon known as the “patent cliff”—a time quickly approaching when several blockbuster brand-name pharmaceuticals will come off patent and will be open to generic competition.

• With first-generation biopharma products reaching the end of their patent lives, a whole new market—biogenerics, or biosimilars—is opening up for those generics companies capable of (or prepared to buy in) the technological expertise required.

• Therapeutic categories quantified and forecast to grow include antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs (e.g., hypolipadaemics and antihypertensives) and drugs for respiratory conditions including asthma and COPD.

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:

• Facilities identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce a human generic FDF or API, or both.

• A site or organization identified in a generic drug submission that is:

• 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:

• Patients increasingly are being empowered to decide whether they will accept or demand generic substitutions, and more governments are demanding healthcare providers prescribe generics.

• The generics industry continues to grow, as an aging population, a strong desire to reduce healthcare outlays and an increasing reliance on generics continue to fuel demand.

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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