Express Pharma

AUGUST 22, 2023

This may likely offset blockbuster drug Keytruda’s expected sales decline following its loss of exclusivity in 2028. AbbVie reported the largest market capitalisation decline in Q2 2023, largely due to the reported decline in sales of its blockbuster drug Humira resulting from biosimilar competition. per cent), Daiichi Sankyo (-13.5

Biosimilars 97

Biosimilars Diabetes 97

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. AbbVie reported a 22.7% Bristol Myers Squibb (BMS) documented a 9.1%

Vaccines 108

Vaccines Drug Pricing Documentation Biosimilars 108

pharmaphorum

AUGUST 4, 2022

Amgen sells a biosimilar version of rituximab so Tavneos slots in alongside that therapy, and the company also gets three early clinical-stage pipeline candidates, namely an oral PD-1/PD-L1 inhibitor and two CC chemokine receptor-targeting drugs for inflammatory diseases.

Biosimilars 98

Biosimilars 98

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

pharmaphorum

JUNE 16, 2025

Zurzuvae sales reached just under $14 million in the first three months of this year, and Supernus will make additional payments to Sage shareholders in the form of contingent value rights (CVR) worth a dollar apiece if annual sales going to Supernus top $250 million in the US by 2027 and $300 million by 2028.

Diabetes 59

Diabetes Pharmaceutical Companies Pharmaceutical Companies Biosimilars 59

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 72

Biosimilars Pharmaceutical Companies Pharmaceutical Companies Labelling 72

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

JULY 10, 2025

Major Elements of the Louisiana Law: Bans 15 additives in public school, or nonpublic schools receiving state funds, meals (food and beverage) starting in the 2027–2028 school year, including: Artificial sweeteners like aspartame and saccharin. Preservatives such as BHA and BHT. Synthetic dyes.

Labelling 66

Labelling Packaging Communication 66

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