STAT

FEBRUARY 9, 2023

WASHINGTON — The Senate Judiciary Committee on Thursday passed legislation to prevent drug companies from gaming the patent system to delay competition from cheaper generics, but members in both parties said they still have concerns about the reforms. Its basic patent expired in 2016.

Biosimilars 245

Biosimilars Drug Pricing 245

pharmaphorum

JANUARY 28, 2021

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

Biosimilars 119

Biosimilars Insurance Coverage and Processing Drug Pricing Diabetes 119

pharmaphorum

MAY 12, 2021

Biosimilars firm Alvotech has filed a lawsuit that challenges AbbVie’s legal defences surrounding the inflammatory disease drug Humira in the US. Humira is due to face competition from a gang of cheaper biosimilar near-copies in 2023, when the blockbuster drug’s patent protection runs out in the US.

Biosimilars 105

Biosimilars Drug Pricing 105

Safe Biologics

FEBRUARY 1, 2024

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

Drug Patent Watch

JANUARY 7, 2025

The Importance of Generic Drugs in Healthcare Generic drugs offer several benefits to patients and the healthcare system: Cost-effectiveness: Generic drugs are typically much cheaper than brand-name medications, making treatment more accessible to patients. ” JAMA, 2016. Association for Accessible Medicines.

Communication 77

Communication Dosage Drug Pricing Packaging 77

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The approval of Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to Janssen’s STELARA (ustekinumab) is noteworthy given that it received designation as interchangeable. Below are some of the top regulatory developments from 2023.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

Big Molecule Watch

JANUARY 19, 2024

As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered on the Big Molecule Watch.

Biosimilars 58

Biosimilars Dosage Drug Pricing 58