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EMA Pilot Will Provide Tailored Advice to Biosimilar Developers, Similar to FDA Process


Beginning this month, the European Medicines Agency (EMA) will offer biosimilar manufacturers a chance to receive tailored scientific advice on their drug’s development prior to submission of a formal application. These meetings will resemble some stages of the FDA’s recommended biosimilar development process.

The EMA pilot program, which was announced last December, will give drug makers individualized feedback on data submitted to the agency’s Scientific Advice Working Party before the final marketing authorization application. The pilot differs from the standard scientific advice procedure in that it allows for an in-depth assessment of trial data and offers specific recommendations for future tests and next steps, not just suggestions on the general development strategy.

The pilot will accept 6 participants after reviewing the applications’ suitability. Only 1 request for the tailored advice will be granted per month, and the process will take a month longer than the traditional scientific advice procedure.

In the announcement, the EMA wrote that this pilot aims to “provide developers of biosimilars with advice on the studies/tests they should be conducting” based on the submitted data. It noted that submissions that undergo this enhanced process are not guaranteed acceptance of their final authorization applications.

Similarities With the FDA Program

As the extent of advice offered by the EMA will vary depending on the evidence submitted, the pilot can be compared to 2 stages of the FDA’s biological product development (BPD) process as outlined in draft guidance released in November, “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” In these guidelines, the FDA explains the 5 types of formal meetings that may occur between drug makers and FDA representatives before the drug approval application is submitted.

A BPD Type 2 meeting can be arranged by a drug maker seeking targeted advice to answer a specific question on an issue like study design. This type of meeting can encompass “substantive review of summary data, but does not include review of full study reports.” A Type 3 meeting, meanwhile, offers in-depth data review of full study reports and guidance from the FDA on the proposed drug’s similarity to the reference drug and any further tests needed.

Applicants can request as many of these meetings as necessary throughout the drug’s development, though the FDA does charge a one-time fee to participate in the program. Drug makers are not required to participate in each meeting stage.

According to the draft guidance, the FDA encourages drug makers to use these meetings “to optimize product development and facilitate submission of marketing applications.” The FDA’s website on the biosimilar approval process notes that manufacturers should take advantage of this opportunity to obtain input at an earlier stage, especially as FDA officials may determine during this review process that an element of the required information to be submitted with the application is unnecessary for that particular drug.

These feedback efforts by the EMA and FDA, therefore, can be invaluable to drug makers preparing to submit biosimilar applications, as the input may expedite the approval process and reduce the number of rejected submissions.

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