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Generic Lovenox: 505j or 505(b)(2)

Today, Marwood Group Advisory Services broadcast an e-mail giving its thoughts on the approval of Momenta Pharmaceutical’s generic of Lovenox®. This is a very nice write up of the regulatory history, including the summary of the Citizen Petition filed by Sanofi- Aventis challenging such approval, but it contains a glaring error. Upon approval and an unfavorable reply to the Citizen Petition Sanofi filed suit. Marwood’s summary stated:

Sanofi filed its complaint with the U.S. District Court for the District of Columbia.  The suit alleges that the FDA exceeded its authority under Section 505(j) of the Food, Drug and Cosmetic Act (FDCA), and ignored its own precedent regarding approval of generic drugs.  According to Sanofi, the FDA required Momenta to submit additional data demonstrating the safety and effectiveness of its product.  The company claims that the FDA disregarded FDCA Section 505(j)(2)(A), which “specifically precludes FDA from requiring the submission of such [safety and effectiveness] information.”  If the FDA required Momenta to submit such clinical study data, which the FDCA does not require of ANDA applicants, it could be argued that the approval should have been executed under FDCA Section 505(b)(2) rather than 505(j).  A product approved under 505(b)(2) is not bioequivalent to the reference product [my highlight], and is not necessarily AB equivalent.  Thus, it may lose an important market advantage, as the ability to directly substitute a generic product is a key driver of generic adoption.

Readers of this blog should recognize that the highlighted section is wrong. On the contrary, many products approved under 505(b)(2) are bioequivalent to their reference listed product (RLD). These products may also be rated AB. 505(b)(2) may be used to obtain approval for products that not bioequivalent, and some may argue that is the usual case, but a review of the products approved under 505(b)(2) will confirm that most products are bioequivalent to the RLD.