Center for Biosimilars®
WEBMarket remonopolization by a biosimilar drug in Poland led to significant price increases for etanercept, resulting in over €3.42 million in excess health care costs, according to a recent study. Sandoz Reports 29% Growth in Biosimilar Revenues for First Half of 2024. By Skylar Jeremias. August 27th 2024.
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much …
FDA Approves First Subcutaneous Infliximab Product - Center for …
WEBOct 23, 2023 · The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab). The intravenous version of Zymfentra is marketed as Inflectra (also, infliximab-dyyb), Celltrion's ...
Amgen Executive Weighs the Challenges for Interchangeable …
WEBJun 25, 2021 · On March 23, 2020, insulins and growth hormones began to be regulated under the Biologics Price Competition and Innovation Act, and this means that they, too, could be approved as biosimilars and interchangeables. But for insulins, the requirements for an interchangeable designation are far less stringent. These agents are less complex …
FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera
WEBMar 12, 2019 · The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a …
Switching Among Multiple Infliximab Biosimilars Does Not Cause ...
WEBJun 17, 2019 · A new study has found that switching among multiple biosimilar infliximab products was not associated with increased immunogenicity in patients with inflammatory diseases. The study, presented at the European League Against Rheumatism European Congress of Rheumatology 2019, was conducted at a single center in France. 1.
FDA Releases Guidance on Biologic, Biosimilar, and …
WEBMar 7, 2019 · The FDA no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, according to an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics ...
FDA Finalizes Guidance on Interchangeable Biosimilars
WEBMay 10, 2019 · The FDA has released its long-awaited final guidance on demonstrating interchangeability of a biosimilar with its reference. The guidance is intended to help biosimilar developers demonstrate that their products are interchangeable with a reference biologic for the purposes of submitting their marketing applications or supplementing …
In the Effort to Develop Global Comparator Products, Biosimilars …
WEBFeb 1, 2019 · However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development. Suzette Kox, MPharm, …
Understanding the Risks, Opportunities, and Prospects of …
WEBFeb 14, 2020 · Entering 2020, we have the opportunity to take a moment, look back, and reflect on the lessons learned of the previous decade with regard to biosimilars. The road to a successful biosimilars market has been anything but straightforward. With complications including a slow rate of approval, extended delays in product launches due to patent ...