The Food and Drug Administration (FDA) on Friday issued draft guidelines on its interpretation of "as a license" provision of the Act Biological Price Competition and Innovation (BPCIA) in 2010.
In short: The FDA will not approve a pending application or tentatively approved for a biological product under the Federal Food, Drug and Cosmetic (FD & C) of the Act after March 23, 2020.
The design of the BPCIA states: "An approved the request for an organic product in accordance with Article 505 of the Act cosmetic Federal Food, Drug, and [FD & C] (21 USC 355), it resembles a license for the biological product under that section 351 [of the Law on public health Service (PHS)] on the date that is 10 years after the date of enactment of [BPCIA] ".
FDA interprets this provision to mean that the March 23, 2020, will cease to exist applications for biological products that have been approved under section 505 of the FD & C Act, as new drug applications (NDA) (or, as the case abbreviated applications for new drugs (ANDA)) and will be replaced by approved biologics license applications (Blas) under section 351 (a) or 351 (k) of the PHS Act, if applicable.
Rob Cerwinski, a partner in the IP Litigation Group Goodwin Procter, said the point that the administration, the FDA wanted to avoid companies that could invest in the decision to submit under a confidentiality agreement or 505 (b) 2, or ANDA way the FDA generally accepted.
"It is to slow down the process of monitoring organic products that are simple enough that they would not have to go through the route of biosimilars" he said.
Approval of new insulins is an example in which the approval route was reduced. In December, the FDA approved Eli Lilly Basalgar as an injection followed by glargine insulin for diabetes, a (b) 2 application 505 is partly based on the request of Lantus Sanofi. However, as the FDA notes, "without insulin glargine product they are registered under the Act, the Public Health Service, so there is no" reference product "for a biosimilar product proposal."
The FDA said it recognizes that this interpretation of the law could have a significant impact on development programs for all protein products proposed to be made under section 505 of the FD & C Act that are not able to receive the final approval on 23 March 2020 also provides recommendations on what to do to these sponsors in the draft guidelines.
Although most therapeutic biologicals have historically been authorized Act Public Health Service (PHS), the FDA, "Some protein products (eg, insulin analogues and insulin, human growth hormone, the pancreatic enzymes, follitropin products) historically have been approved under the FD & C Act the law of the ICPD has changed the law under which these protein products are regulated by changing the legal definition of a "biological" in the PHS Act to include a "protein (except any chemically synthesized polypeptide). "
Interpretation of exclusivity
Specifically, the FDA said it interprets this section BPCIA and section 351 (k) (7) of the PHS Act "to refer to a request for an approved biological agent in accordance with Article 505 FD & C Act shall be considered as a license for the biological product in accordance with Article 351 (a) of the PHS Act 23 March 2020 will not have been "first license under subsection (a)" for the purposes of Article 351 (k) (7 ) of the PHS Act and therefore will not receive exclusivity period under section 351 (k) (7) (a) and (B) the PHS Act. "
Biological otherwise they benefit from an exclusivity period of 12 years, during which the FDA can not approve the application 351 (k) for a biosimilar and an exclusivity period of 4 years, during which the applicant may not submit (k ) application 351, which starts at "the date on which the reference product has been authorized under paragraph (a) [concerning Article 351 210 (a) of the PHS Act]".
Cerwinski said management will not grant exclusivity only 12 years due to the transition of certain products.
"None of the provisions of the Act BPCI suggests that Congress intended to grant biological approved under section 505 of the FD & C Act - some of which were adopted decades - after a period of exclusivity considered to have a license under the PHS Act that prevents biosimilar or interchangeable competing products in many product categories up to 2032 years, "the FDA said.
"Companies that have chosen to present NDA BLA heard rather than exclusivity, these expectations are not changed," he said.
The promoters of development programs for the protein product proposed should assess whether a submission under Article 505 of the FD & C Act would allow sufficient time for the approval of the NDA (or, where applicable ANDA) before 23 March 2020, the FDA added, and companies must consider whether the presentation may require a second opinion and for some types of applications, whether patents or exclusivity unmatured may delay final approval.
The FDA also believes that developers protein product proposals to the presentation in a 505 (b) (2) The application must wait.
