pharmaphorum

AUGUST 2, 2022

The switch to an injectable version of the drug could also help to extend the commercial lifespan for Tecentriq and reduce the impact when biosimilars of the IV version reach eventually reach the market – assuming of course Roche can persuade clinicians to switch. Results from a trial in first-line NSCLC are due in early 2023.

Chemotherapy 105

Chemotherapy Biosimilars 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).

Labelling 64

Labelling 64

Express Pharma

DECEMBER 20, 2024

At the same time, Indias growing focus on tapping the $36 billion global biosimilars market highlights the need for real estate infrastructure that can support advanced manufacturing capabilities. As these trends unfold, life sciences real estate will need to include carbon-neutral and resource-efficient models across its offerings.

Biosimilars 103

Biosimilars Vaccines 103

pharmaphorum

JANUARY 14, 2021

Biosimilars accelerate. Biosimilars are now a long-established feature of European markets, and an increasingly well-established element in the US. 2021 marks the start of the era when these healthcare systems really need biosimilars to come good on their promise to realise cost savings. Focus on customer engagement impact.

Biosimilars 71

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 71

Safe Biologics

MAY 10, 2024

Biden Administration HHS Budget Would Permit Third-Party Substitution of All Biosimilars On March 11th, the Biden Administration released its FY25 HHS Budget. and Europe alike, prescribers can already substitute any biosimilar for its reference product. Currently there are 10 biosimilars that can be substituted by U.S.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

European Pharmaceutical Review

AUGUST 21, 2023

billion sales globally by 2029, this could offset Keytruda’s decline sales expected after its loss of exclusivity in 2028, GlobalData highlighted. This is mainly due to the reported decline in sales of Humira, a consequence of biosimilar competition. With the company’s monoclonal antibody drug candidate PRA023 predicted to reach $2.1

Biosimilars 98

Biosimilars Diabetes Vaccines 98

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.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Big Molecule Watch

APRIL 3, 2025

GLOBAL BIOSIMILAR UPDATES Celltrion Bolsters Biosimilars Market Position in Italy Celltrions ustekinumab biosimilar, STEQEYMA , has won its first bid within 2 months of its launch in January of 2025. Under the contracts, STEQEYMA will be supplied to these regions until 2028.

Biosimilars 40

Biosimilars 40

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.

Labelling 52

Labelling Documentation 52