Drug Review

Fresenius has acknowledged that the FDA’s draft guidance could shorten approval timelines and cut trial costs for biosimilars, even though it “may have not fundamentally changed the existing framework.”

Outlook Therapeutics believes its revised filing addresses the FDA’s sole remaining concern from an August complete response letter, setting up a potential mid-2026 decision on its wet AMD therapy.

Amgen’s CEO Robert Bradway has reaffirmed confidence in the company’s Humira biosimilar, Amjevita, as the company tackles with an ever-growing population of denosumab biosimilars.

With the FDA moving to ease biosimilar approval requirements, Amgen’s leadership urged Washington to preserve the high regulatory bar that has favored experienced biologics manufacturers.

As the FDA reviews its lead ADHD candidate, a dexmethylphenidate hybrid, Cingulate is pairing scale-up manufacturing with AI-driven marketing to smooth its transition into commercialization.

Xspray Pharma has welcomed an “important milestone” after the FDA agreed to review its proposed hybrid version of Tasigna (nilotinib), which the Swedish firm says has shown a markedly reduced food effect compared to the reference product.

AEON Biopharma will meet with the FDA next month to review its 351(k) biosimilar pathway analytical plan for the firm’s proposed biosimilar to Botox.

A busy month for the EMA’s Committee for Medicinal Products for Human Use saw nine biosimilars recommended for approval.

Alvotech has welcomed a trio of Japanese biosimilar approvals, set to be sold via its local commercial partner Fuji Pharma, though the firm remained tight-lipped about future potential launch dates.

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.