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On October 2nd 2017, the FDA held a 2-day meeting to discuss how generic drug development – especially that for complex generics – could be better streamlined. The FDA has clearly noticed that competition in the complex generic space is increasingly slow and hard to generate and, as such, it has released two new draft guidance documents.
The first draft guidance document relates to formal meetings between FDA and ANDA applicants, and ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin. This guidance will help to assist potential as well as actual applicants in generating meeting requests and with their subsequent submissions. The guidance also helps to navigate the meeting package required for complex products, as per GDFUA II (Generic Drug User Fee Amendments Reauthorization of 2017).
The second draft guidance document is aimed at helping perspective ANDA applicants determine whether a submission for certain synthetic peptide drugs should be submitted as an ANDA as opposed to an NDA. This centres primarily on the complex issue of establishing bioequivalence for these products due to difficulties in blood level detection, or a product’s localised as opposed to systemic mechanism of action.
The above documents follow a growing trend from the FDA. In fact, back in June, the FDA took two major steps to opening up generic competition. The first was a release of a list containing off-patent products with little or no competition. The list is split into two parts: part I of the list identifies those drug products for which the FDA could immediately accept an ANDA without prior discussion, while part II identifies drug products involving potential legal, regulatory, or scientific issues which should be addressed with the Agency prior to submission of an ANDA. The second step was prioritising the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug. The aim of this step is to free up competition and to tackle the growing cost of healthcare.
The regulatory landscape for generics across the globe is constantly evolving and at ELC Group we can help identify and harness new areas of business growth and portfolio expansion through these emerging regulatory channels and opportunities.