Rheumatology

In India, Patient Advocates Lobby for Modernized Biosimilar Development Standards

January 8th 2022

By Tony Hagen

In India, an emphasis on outdated biosimilar testing has restricted market entry of these products and discouraged manufacturers, patient advocates contend.

Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab

January 5th 2022

By Tony Hagen

The companies hope to gain FDA approval for a high-concentration, citrate-free version of Hadlima, an adalimumab biosimilar that was approved in a lower concentration in July 2019.

Biosimilar Savings Through 2025 Could Total $38.4 Billion

January 4th 2022

By Tony Hagen

Savings from adalimumab biosimilars, which won't enter the US market until 2023, account for a significant share of the total, investigators said.

Report: Biosimilar Competition in Europe

January 1st 2022

By Tony Hagen

Biosimilars have produced more than $20 billion of savings in Europe, but more use of these agents is needed.

The Top 5 Biosimilars Legal Stories of 2021

December 31st 2021

By Tony Hagen

The top legal stories in biosimilars over the past year concerned etanercept and adalimumab biosimilars and access to insulin.

Highly Confident, Biosimilar Companies Notch Global Commercialization Deals

December 24th 2021

By Tony Hagen

With fewer of the risks associated with novel drug development, biosimilar candidates allow manufacturers to plan far into the future for marketing needs.

In Canada, More Mandatory Switching

December 23rd 2021

By Tony Hagen

In Canada, a new jurisdiction inaugurates mandatory switching to biosimilars.

The Top 5 Biosimilar Regulatory Stories of 2021

December 22nd 2021

From the approval of the first insulin glargine biosimilar (Semglee) to the potential for extreme biosimilar competition in the adalimumab market, 2021's regulatory stories were popular with readers.

FDA Approves Yusimry, the Seventh Adalimumab Biosimilar

December 21st 2021

By Tony Hagen

Coherus BioSciences said the 40 mg subcutaneous formulation of adalimumab would be launched on or after July 1, 2023, in agreement with AbbVie, maker of Humira, the reference product.

AbbVie Returns to Court in Effort to Block Alvotech Adalimumab Biosimilar Candidate

December 20th 2021

By Tony Hagen

After an unsuccessful attempt to get an Illinois court to block the distribution of Alvotech's adalimumab candidate, AbbVie has tried again in a new forum.