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Biowaver submissions

Pharmaceutical company turns to elc group to navigate EU biowaver approvals for a new generic drug

Knowing a biowaver application was appropriate for its new generic medicine meant this company could eliminate the need for a time consuming and expensive bioequivalence study and plan with certainty a ‘go to market’ strategy and timeline.

“Gaining a detailed peer review from elc group meant we knew we could pursue a biowaver strategy with certainty. The commercial benefits of knowing this from the outset were immense.”

The Challenge

Preparing a regulatory strategy to maximize biowaver approvals in selected EU countries would be key to gaining timely market share for a new generic drug.

With the clock ticking down on the expiry of EU patents for a major brand name gastric treatment, this pharmaceutical company wanted to ensure it was positioned to go to market with a generic equivalent in the most time and cost efficient manner.

With clinical data prepared, the first step was to confirm whether there were strong grounds for moving forward with a biowaver submission strategy. An error of judgement at this stage would prove costly from a commercial perspective.

Discovering part way through the submission process that a bioequivalence study was required for its treatment would represent a major setback, with significant repercussions for the company’s commercial team in terms of the launch timelines and country marketing strategies.

Having confirmed a biowaver strategy was indeed appropriate, the company next needed to establish whether a national or pan European submission tactic was best, and ensure its biowaver submissions were properly prepared to assure first time approval.

To gain expert insights and support with all these issues, the regulatory team turned to the elc group.

The Solution

Taking advantage of elc group’s clinical and regulatory experts meant the right route to licensing could be defined from the outset, and the entire application process could managed be managed within projected timelines.

Understanding if there were strong grounds to pursue a bioequivalence study exemption strategy was an essential first step. Gaining early confirmation that a biowaver was suitable for its product meant the company could put the right regulatory strategy in place early on, and avoid investing millions of Euros pursuing a potentially inappropriate pathway to licensing.

With over a decade of experience in biowaver applications and a deep understanding of the regulatory requirements related to bioequivalence waivers, elc group is uniquely positioned to provide an expert peer group review of clinical data.

The elc group peer group, made up of expert leads from its formulation, development and regulatory teams, dissected the new product and assessed it against conformance to strict EU safety guidelines. Within an extremely short window of time elc group was able to confirm the new drug would satisfy the stringent requirements set for a biowaver application.

“Their exceptional experience in this field meant elc group was able to give us ‘on the ground’ insights that proved invaluable. While everyone can read the guidelines, only elc know and understood the ‘unwritten rules’ that apply.”

Having established this all important starting point, elc group next defined an application strategy that would maximize the company’s ability to achieve required licensing in its chosen markets in the most time and cost effective manner.

As part of the consultation process, elc group delivered a detailed evaluation of the costs and risks involved, and liaised closely with the company’s in house commercial and regulatory teams to ensure a business strategy could be developed in line with the regulatory application strategy.

With the application approach defined, elc group took control of drafting all submissions. The entire process, from the preparation and translation of all documentation to liaison with local regulatory authorities, was managed in a timely manner and as an integral part of the procedure.

The Result

Using elc group gave the company immediate access to the knowledge and expertise it needed to confirm if a biowaver strategy was appropriate from the outset. Drawing on its long established working relationships with regulatory agencies across Europe, elc group was able to recommend the best route to achieving biowaver approvals, with the result that there were no unexpected surprises or costly delays.

Thanks to the dedicated resource provided by elc group, license applications were all processed within the target timeline of 210 days.

The benefits of a fully managed biowaver application service from elc group include:

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