The new draft bioequivalence guidance documents cover generics of Takeda’s multiple myeloma drug Ninlaro (ixazomib), attention-deficit/hyperactivity disorder (ADHD) treatment Ritalin-SR (methylphenidate HCl) from Novartis, Bayer’s Aleve-D Sinus & Cold (naproxen/pseudoephedrine) and Merck’s cholesterol lowering medication Zocor (simvastatin) among others, see Table 1.

Revised bioequivalence guidance documents include those for generics of Bristol-Myers Squibb’s hepatitis C treatment Daklinza (daclatasvir dihydrochloride), anticonvulsant felbamate, proton pump inhibitors lansoprazole and dexlansoprazole, and opioid pain treatment oxycodone, among others, see Table 2.

FDA bioequivalence requirements demand that the generic drug performs in the same way in the body and has the same active ingredient(s), strength, dosage form and route of administration as the brand-name reference drug.

Table 1: FDA new draft bioequivalence guidance documents

Table 2: FDA revised draft bioequivalence guidance documents

The draft guidance documents recommend what in vivo and in vitro studies generics companies should carry out in order to demonstrate bioequivalence. The number of studies, the population to be studied, blood sampling time points and analytes to be measured in blood samples are also detailed in the draft guidance documents. Some of the documents also provide discussion on data formats.

FDA also has an overarching guidance document on bioequivalence recommendations for specific products [1], as well as a dissolution methods database.

FDA Commissioner Scott Gottlieb said that to date the agency has ‘now published about 1,600 of these product-specific guidances laying out the path for developing generics to specific products; including more than 350 guidances for developing generics of complex drugs’.

Comments on the draft guidance documents can be posted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. This can be done via the website www.regulations.gov or written comments can be mailed to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Related article
FDA releases 52 new and revised bioequivalence guidelines for generics

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 6]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics

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