Vizient praises FDA’s revolutionary step to deem cost and bolster biosimilar development

Announcement

Vizient, the US-based, well-known, large healthcare performance improvement-focused company serving healthcare providers nationwide, applauded the US Food and Drug Administration (FDA) for taking action to advance biosimilar development and publishing new draft guidance. The latest draft guidance will give clarity on the right time for consideration of comparative efficacy studies (CES) for biosimilar approval, which should alleviate the heavy weight of linked biosimilar approvals in a few cases.

This commendable news represents the agency’s dedication to extending patient access to biologic therapies, which are affordable while balancing efficacy and safety. Vizient has always supported the policies that eliminate unnecessary market regulatory barriers and advance biosimilar adoption to affordable medicines. This involves validating for science-fueled fuelled efficient approval and serving feedback on the FDA’s interchangeability guidance for interchangeable and biosimilar biologic products.

Vizient’s multiyear journey with the FDA

Vizient has maintained consistency in working with various stakeholders and the FDA to strengthen and retain the biosimilar review process. The company’s long-term commitment ensures that physicians, healthcare professionals and pharmacists are prepared and informed to map this emerging changing space of patient care.

The PharmD, BCPS, senior principal, pharmacy solution provider for Vizient, Steven Lucio, said, “Vizient have strongly stood with the FDA’s science-based approach to pipeline the biosimilar approvals while enhancing the standard of quality and safety. By discarding redundant clinical study requirements the FDA is accelerating competition, adoption and extend reach to reasonable biologic treatments for providers and patients.”

Vizient have acted as an advocate, expert commentator and feedback provider to the agency, mainly stressing the concerned areas like biosimilar competition, drug shortages and drug supply chain resilience. The company’s long-standing advisory and collaborative relations have always witnessed the best of the possible changes and initiatives that have made a huge impact in the vast healthcare market.

FDA’s latest initiative paves the way for many biosimilar drug developers and manufacturers to flourish in the market and seek growth and recognition with the affordability and a chance of presenting the potential of the findings.

Further, this decision will help many pharmaceutical and biotech companies to lead and achieve the success of the drug development rate without compromising with quality, efficacy and safety. Alongside, the advancement and development will reframe the future of next-generation medicines, applauding the FDA’s approach towards the biosimilar development and cost concern.