Tagged as: Amjevita

Year in Review: Top Regulatory Developments of 2023

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.  Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…

Read More

CYLTEZO® to Launch on July 1 as the First Interchangeable HUMIRA® Biosimilar

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States.  Boehringer Ingelheim has also announced that with CYLTEZO’s commercial launch, pharmacy-benefit manager Optum Rx (a subsidiary of UnitedHealth Group), which currently covers more than 66…

Read More

Coherus and AbbVie File Dueling Motions for Injunctive Relief Relating to Coherus’s HUMIRA Biosimilar

Our readers may recall that ten HUMIRA biosimilars have been licensed to launch, with Amgen’s AMJEVITA the only one to launch to date and nine others set to launch starting in July 2023.  On June 1, 2023, Coherus issued a press release announcing “that the company plans to launch YUSIMRY™…

Read More

Natasha Daughtrey to Speak at ACI’s 14th Annual Summit on Biosimilars & Innovator Biologics

The 14th Annual American Conference Institute’s (ACI) Summit on Biosimilars & Innovator Biologics will be held on June 27-28, bringing together the “who’s who” of the biosimilars and innovator biologics industries as they gather to discuss and contemplate the impact of critical developments in these industries: biologics becoming the fastest-growing…

Read More

Amgen Launches AMJEVITA—First Biosimilar to HUMIRA in the United States

Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States.  AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,…

Read More

Q3 2020 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from third quarter 2020 earnings reports recently released by biologics and biosimilars companies: Biogen reported a decrease in year over year (YoY) revenue of 6% to $3.4 billion, but a 13% increase to $208 million in biosimilar revenue.  It reported the following YoY revenue for each…

Read More