FDA News

FDA approves Kanjinti, biosimilar to Herceptin

June 13, 2019
The FDA approved trastuzumab-anns for the treatment of HER2-overexpressing breast cancer, as well as metastatic gastric or gastroesophageal junction…
In the JournalsPerspective

No impact on safety, efficacy in etanercept-to-biosimilar switch in RA

June 12, 2019
Patients with moderate-to-severe rheumatoid arthritis who switch from etanercept to the biosimilar etanercept-szzs experienced no impacts on drug…

Battle for Enbrel: Ruling on patent lawsuit could transform US biosimilar marketplace

June 10, 2019
Amgen is currently embroiled in two pivotal court cases surrounding patents for its bestselling etanercept product that could protect it from…
Meeting News

US should ‘learn from Europe’ regarding biosimilar policy, adoption

May 16, 2019
CLEVELAND — The United States continues to lag far behind Europe in terms of biosimilar availability, and officials here should take a lesson…
FDA News

FDA creates final guidance on approval pathway for biosimilars

May 10, 2019
The FDA, as part of the Biosimilars Action Plan, is acting to promote competition in the biologic developer market by providing final guidance for…
FDA News

FDA approves Eticovo, second Enbrel biosimilar

April 26, 2019
The FDA has approved the second biosimilar to etanercept, etanercept-ykro, for all eligible indications of the biologic product, according to an FDA…

Gottlieb resignation raises questions about the future of biosimilars in the US

April 4, 2019
When Scott Gottlieb, MD, announced on March 5 that he would be resigning as Commissioner of the FDA, a ripple went through the health care…
FDA News

FDA approves Trazimera, Herceptin biosimilar, for certain breast, gastric cancers

March 12, 2019
The FDA approved trastuzumab-qyyp for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction…
FDA News

FDA issues draft guidance for biologic, biosimilar naming conventions

March 7, 2019
FDA Commissioner Scott Gottlieb, MD, on Thursday announced that the FDA no longer intends to change the proper names of biological products that…
FDA News

Government shutdown threatens biosimilar approvals, patent litigation

January 18, 2019
As the ongoing partial government shutdown continues in the United States, the FDA has approximately 5 weeks until drug user fees completely dry up…
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