European Pharmaceutical Review

JULY 21, 2023

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026.

Biosimilars 98

Biosimilars Drug Development 98

Express Pharma

MAY 10, 2023

The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion. Development of the biosimilars will ramp-up over the coming 12-18 months.”

Biosimilars 97

Biosimilars Drug Development 97

Safe Biologics

OCTOBER 10, 2023

A Better Reform: Ensuring Savings Are Passed Onto Patients While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains. – View clip.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.

Drug Pricing 52

Drug Pricing Biosimilars Drug Development 52

Safe Biologics

SEPTEMBER 11, 2023

A Better Reform: Ensuring Savings Are Passed Onto Patients While price-setting proponents say beneficiaries will start to see lower drug prices beginning in 2026, there’s no evidence that this is true, and there are better ways to lower out-of-pocket costs- and much faster, Reilly explains.

Drug Pricing 150

Drug Pricing Biosimilars Vaccines Drug Development 150

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. It is extremely difficult, if not impossible, to do the long-term planning and substantial fundraising required for drug development without knowing whether such an important and valuable incentive will be there.

Documentation 64

Documentation Drug Development 64

FDA Law Blog: Biosimilars

DECEMBER 23, 2024

This means that, at the current moment, FDA cannot award any priority review vouchers for rare pediatric disease product applications unless it is for a drug that was designated as a drug for a rare pediatric disease not later than December 20, 2024, and such application is approved not later than September 30, 2026.

Drug Development 59

Drug Development 59