Will Specialty Approvals Affect the Generic Landscape?

Eileen Oldfield, Associate Editor
Published Online: Tuesday, April 15, 2014
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Although new molecular entity approvals remained relatively steady for the past 3 years, a marked increase in the amount of large-molecule, biologic drugs could call the generic drug market’s future into question.

According to the FDA’s Center for Drug Evaluation and Research Report for 2013, the agency approved 27 new molecular entities last year, which is on par for most years since 2004. In calendar years 2011, 2012, and 2013, the preponderance of specialty medication approvals held relatively steady as well, and continued to outnumber approvals for traditional medications.

The annual CDER report catalogues approvals for biologic entities and traditional small-molecule drugs, and many of the approvals were for medications with specialty indications: cancer medications, hepatitis C therapies, HIV antiretrovirals, and several therapies for rare diseases have dominated recent reports. Only 9 new molecular entities approved in 2013 were for nonspecialty or orphan conditions, whereas 15 new molecular entities were indicated for specialty or rare conditions. The remaining 3 approvals were for molecular entities to assist in magnetic resonance imaging, positron emission tomography, and lymphatic mapping imaging technologies.

The traditional, small-molecule new molecular entities approved in calendar year 2013 include therapies for major depressive disorder, type 2 diabetes mellitus (T2DM), chronic obstructive pulmonary disease, epilepsy, vasomotor symptoms associated with menopause, cutaneous fungal infections, and moderate to severe dyspareunia associated with menopause.

Thirty-three percent (9 of 27) of new molecular entities approved during 2013 were identified as first-in-class drugs, meaning the therapies used a new and unique treatment mechanism. Among the first-in-class drugs specifically mentioned in the FDA’s report, only 1—T2DM treatment Invokana (Janssen Pharmaceuticals)—is a traditional, small-molecule medication. Meanwhile, the FDA reported approving 9 therapies for rare or orphan diseases; 4 of these therapies—Adempas (Bayer HealthCare Pharmaceuticals), Imbruvica (Janssen Biotech), Kynamro (Genzyme), and Mekinist (GlaxoSmithKline)—were included in both the first-in-class designation and the orphan disease designation.

The number of new drug applications has also held steady, and the agency will not see approvals increase until applications increase as well, it said.

The increase in biologic medication approvals could present additional concerns for generic manufacturers, as the manufacturers await a clear FDA pathway for developing and approving biosimilar medications. Four biosimilarity guidances remain in draft form; they cover quality considerations, scientific considerations, industry guidance, and formal meetings between the FDA and biosimilar product sponsors or applicants. Meanwhile, the number of states approving or introducing biosimilar substitution legislation continues to grow, with the amount of oversight varying state to state.

In addition to the lack of a clear biosimilar approval pathway, the “evergreening” practices used to extend small-molecule brand name drug patents have come into question. Existing patent law allows patent holders to introduce enhancements to their already-patented products—a practice that is considered a loophole by some because it can extend an existing patent. The strategies can include obtaining multiple patents for various characteristics of the same product, which can extend patents beyond the time period specified when the drug is initially approved, and introducing new product formulations. Prior to the prescription drug patent cliff, evergreening had been used to extend brand name exclusivity.

The practices lead to increases in overall health expenditures, studies analyzing pre–patent-cliff spending determined. The problem occurs when the new product formulations do not equate to actual clinical differences or improvements.

“GPhA continues to oppose brand company maneuvers that hinder access to more affordable generic medicines,” Ralph G. Neas, GPhA president and CEO, said in an e-mail to Pharmacy Times. “Diverting funds away from innovation that would address unmet needs to instead focus on extending patent life does a disservice to patients and consumers.”

In one study, an analysis of evergreening practices in hospital and community pharmacies in Geneva, Switzerland (conducted between 2000 and 2008; published in the June 2013 edition of PLoS One) determined that €41.1 million was spent on follow-on brand name drugs, and estimated savings from replacing the follow-on drugs with generic medications at €14.4 million.

The impact of patent extensions after the patent cliff is yet to be seen, however, and whether the same tactics will come into play for biologic products remains unknown. At present, industry reports, including several issued by the IMS Institute for Healthcare Informatics, have noted the savings on prescription drug spending associated with the influx of generic alternatives after 2012, the year commonly considered the patent cliff. The medications contributed to the first decline in US drug spending since the organization began tracking drug spending. A similar occurrence might be welcome for patients grappling with the high costs associated with biologic products.

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