FDA Gives Final Word on Interchangeable Biosimilars
New guidance from the Food and Drug Administration explains what manufacturers must do to qualify their biosimilar medicine as interchangeable with its reference product.
FDA to Tweak Naming System for Biological Medicines
One key to tracing how innovative biological medicines impact patients hinges on a deceptively simple issue: how the drugs are named.
Fourth Annual National Policy & Advocacy Summit on Biologics and Biosimilars
Languishing in a hospital bed after surgery for life-threatening Crohn’s disease, San Diego Chargers’ Rolf Benirschke, dangerously underweight and saddled with ostomy bags at only 24 years old, couldn’t see the value of going on. But with top-notch medical care and the support of his family and teammates, Benirschke rallied. He ultimately returned to the […]
Biologics Summit Explores “The Value Proposition”
Languishing in a hospital bed after surgery for life-threatening Crohn’s disease, San Diego Chargers’ Rolf Benirschke, dangerously underweight and saddled with ostomy bags at only 24 years old, couldn’t see the value of going on.
FDA Plots Progress Toward Biosimilar Access
The Food and Drug Administration is tired of waiting. Of the 11 biosimilars approved by the agency, only three are available on the U.S. market. The therapies are poised to provide patients with additional – and potentially lower-cost – options for treating rheumatoid arthritis, Crohn’s disease, cancer and other diseases. But not unless patients can access them.
2018 National Policy & Advocacy Summit on Biologics and Biosimilars
On April 17, 2018, the Institute for Patient Access convened the third annual National Policy and Advocacy Summit on Biologics and Biosimilars in Washington, DC. Patients, government representatives, physicians and advocates came together for the day-long event, which celebrated innovation, highlighted the power of biologic and biosimilar treatments, and examined the barriers to […]
2017 National Policy and Advocacy Summit on Biologics and Biosimilars
On April 6, 2017, the Institute for Patient Access convened the second annual National Policy and Advocacy Summit on Biologics and Biosimilars in Washington, DC. Patients, government representatives, physicians and advocates explored throughout the day-long event how more biological options present both new challenges and new possibilities for treatment. The event was co-sponsored […]
GAfPA “NOR-SWITCH” Paper Explores Impact of Biosimilar Switching Research
Data from a clinical study in Norway may soon explain the effects of switching stable patients from a biologic medicine, infliximab, to its biosimilar counterpart. But, as the Global Alliance for Patient Access argues in a new white paper, policymakers must accurately interpret what the NOR-SWITCH study will – and will not – demonstrate about the safety of switching.
Biologics Prescribers Collaborative Joins AfPA
The Biologics Prescribers Collaborative, a group representing physicians who regularly prescribe biologics, has joined the Alliance for Patient Access.
Biosimilars Panel Highlights Need for Patience, Transparency
A Politico Pro-Health panel on biosimilars invited straight talk from FDA Director Janet Woodcock, MD, who acknowledged the need for a safe, incremental approach to adopting biosimilar medications.
