November 17th 2020
By Tony Hagen
The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.
November 11th 2020
Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.
HHS Secretary Alex M. Azar said efforts and policies to counter a sharply upward drug price trend have been successful, in a talk with the Association for Accessible Medicine.
November 10th 2020
The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.
Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.
November 9th 2020
By Skylar Jeremias
Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.
November 5th 2020
Medicines for Europe, a generic and biosimilar trade association, contends in a white paper that legal and regulatory loopholes increasingly keep competing drugs off the market.
November 4th 2020
Alberta, Canada’s deadline for switching patients to biosimilars is months away, but the province has already seen some success with the new program.
November 3rd 2020
Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but modifications to regulatory policy could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.
Certain biosimilar studies are performed out of an abundance of caution and good marketing sense, although science has leapfrogged the need for these trials, panelists said at the Terrapinn Festival of Biologics Basel 2020.
