Tagged as: FDA

Equillium Announces Interim Data Results for Patients Treated with Itolizumab in Acute GVHD Study; Plans to Study Itolizumab in Patients with Severe COVID-19

BioSimilars Patent Dance

On August 10, 2020, Equillium, Inc. announced its interim data for its study of itolizumab as a first-line treatment in patients with acute graft-versus-host disease (GVHD).  GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants, and is the leading cause of non-relapse mortality…

Read More

Alvotech and Teva Announce Strategic Partnership to Collaborate in the U.S. Biosimilar Market

Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S.  Under the partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, and Teva will be exclusively commercializing the products in…

Read More

EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

Read More

Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

Read More

FDA Approves First New Biosimilar of 2020

On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…

Read More

FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders

As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and…

Read More

Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product

Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…

Read More

FDA Issues Final Definition for “Biological Product”

The FDA recently issued a final rule regarding the definition of “biological product,” amending its previous definition.  The statutory definition of “biological product” included “protein (except any chemically synthesized polypeptide),” but this past December Congress removed the parenthetical excluding “any chemically synthesized polypeptide.”  Now, the FDA has announced that it…

Read More