DrugBank

SEPTEMBER 26, 2024

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

Biosimilars 98

Biosimilars Clinical Trials Production FDA 98

DrugBank

AUGUST 9, 2024

Shorter exclusivity periods, driven by patent challenges and the introduction of generic or biosimilar competitors, significantly contribute to declining ROI. When a drug loses patent protection, generic or biosimilar versions can enter the market, leading to a rapid decline in sales for the original brand-name drug. trillion by 2028.

Pharmaceuticals 98

Pharmaceuticals Research Pharmaceutical Companies Clinical Trials 98

The Pharma Data

APRIL 6, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S.

Regulations 52

Regulations Biosimilars Government Production 52

The Pharma Data

APRIL 8, 2021

Led by the growing reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health.

Regulations 52

Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024. Final Guidance at 2.

Compliance 105

Compliance Drugs Pharmacy Licensing 105

FDA Law Blog: Biosimilars

OCTOBER 6, 2023

The Proposed Rule states that Stage 4 and Stage 5 would not begin before October 1, 2027, and April 1, 2028, respectively, in order to enable laboratories to participate in negotiations preceding user fee reauthorization in 2027 (taking effect in FY2028, which begins on October 1, 2027).

Laboratories 64

Laboratories FDA Regulations Production 64

FDA Law Blog: Biosimilars

JANUARY 2, 2025

The compliance date is February 25, 2028. FDA believes that such a standardized graphic will further support FDAs goal of helping consumers identify food products that can be the basis of healthy eating patterns consistent with the DGs. The final rule is effective 60 days from December 27, 2024, i.e., February 25, 2025.

FDA 52

FDA Production Science Compliance 52