After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.
Rituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.
The biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.
In a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.
The move will create Europe's largest generics company.
The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.
The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
Coherus released its earnings report for the last quarter of 2021 and for the year as a whole.
Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.
Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
Pharmacokinetics of CT-P10 were highly similar to originator products.
Intellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation.
The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
As one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.
The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.