The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.
The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs (NBCDs) such as nanomedicines, including drug-carrying liposomes—can be decreased. Furthermore, access to these high-quality drugs can be improved for the global community if steps are taken to improve regulatory alignment processes undertaken by the FDA, the European Medicines Agency (EMA), and the World Health Organization (WHO), according to the conclusions of a conference on worldwide regulatory frameworks for the approval of complex drug products and their follow-on versions, held last autumn at the New York Academy of Sciences.
All stakeholders at the meeting, including scientists from innovator and generic companies, academia, and regulatory bodies from around the world, agreed that complex drugs and their follow-ons should be evaluated with great care, and that it is an absolute necessity to define their critical attributes in order to ensure the safety and efficacy of these products. With ever-increasing numbers of biosimilars under development, this discussion is critically important if overall expenditures in healthcare are to be reduced through the use of high-quality, safe, and effective biosimilars.
In an associated white paper published in the Annals of the New York Academy of Sciences on April 26, 2017, Leonie Hussaarts, PhD, program manager at Lygature, Netherlands, and colleagues wrote of the development and regulatory challenges for biosimilars and follow-on versions of complex biologics, as well as the challenges of bringing these products to patients. They note that, although the stakeholders attending the meeting often had different and even conflicting interests, they agreed that the most important stakeholder is the patient.
Outstanding challenges that stakeholders believe must be addressed include the following:
“It is in our hands to bring high-quality, safe, effective, and affordable medicines to patients in a timely and efficient matter,” the white paper concludes. “A critical assessment of how we currently work within the existing frameworks and whether these provide us with the highest chances of bringing those medicines to patients, requires this community to critically reflect on its activities.” Science-based discussions, joint definition of the next steps, and reflection on activities will tell stakeholders whether they are moving in the right direction and whether regulatory frameworks reflect the best science, are fit for purpose, and are ready for the future.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.