Tag: Humira

The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab

In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr). HADLIMA The approval for Hadlima covers the following indications: Rheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAnkylosing spondylitisCrohn’s disease in adultsUlcerative colitisPlaque psoriasis Formerly known as SB5, … Continue reading The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab →

$7.6 Billion Estimate on Savings Lost From Approved, Nonlaunched Biosimilars Could Be Low

$44 Billion by 2024. $250 Billion by 2024. Whatever. I’ve not been very impressed by the many attempts to estimate how much money biosimilars could save the US health care system. Even the more well-known estimates of biosimilar savings, like those from RAND and Express Scripts, have been little more than games of "pin the … Continue reading $7.6 Billion Estimate on Savings Lost From Approved, Nonlaunched Biosimilars Could Be Low →

The FTC and Patent Thickets: A Conversation With Kevin M. Nelson, Esq., Partner, Schiff Hardin LLP, Chicago

On May 7, the Senate Judiciary Committee held hearings on how to clear the patent thickets obstructing access to lower-cost biosimilars. One of the key avenues raised during the hearings was moving the Federal Trade Commission (FTC) directly into the fray. We asked Kevin M. Nelson, our go-to expert on intellectual property issues, for his … Continue reading The FTC and Patent Thickets: A Conversation With Kevin M. Nelson, Esq., Partner, Schiff Hardin LLP, Chicago →

A Quick Look Back: Why We Misread the Signs

In the biosimilars arena, at least in the US, history seems to be truncated. Policy changes occur in rapid fire succession these days, and access scenarios don’t evolve—they just happen or they don’t! Along this brief journey, I’ve taken the opportunity to focus on some of the sign posts that were exceedingly poor maps for … Continue reading A Quick Look Back: Why We Misread the Signs →

A Conversation With Steven G. Avey, MS, RPh

In May 2016, I interviewed Steven Avey, Vice President, Specialty Pharmacy, MedImpact, for the Center for Biosimilars. That conversation speculated on the potential for biosimilars, having only recently experienced the launch of the first biosimilar in the United States, filgrastim-sndz. At the Academy of Managed Care Pharmacy's 2019 annual meeting last week, I sat down … Continue reading A Conversation With Steven G. Avey, MS, RPh →

Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?

As reported by the Center for Biosimilars, a union has filed a class-action lawsuit against AbbVie and the eight prospective biosimilar adalimumab makers who agreed to delay bringing their agents to market through a royalty arrangement. Only Boehringer Ingelheim remains as a biosimilar maker who has an approved version of adalimumab but who has not … Continue reading Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion? →

Biosimilar Bytes

In the absence of really big biosimilar stories with far-reaching implications, let’s start with some interesting bits on biosimilars to begin this week. First, insulin maker Eli Lilly asked the Food and Drug Administration a very interesting question, in comments on the agency’s guidelines on transitional drugs. Lilly requested clarification of the rules under which … Continue reading Biosimilar Bytes →

More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement

The multitude of companies that have lined up to sign 2023 licensing agreements with Abbvie on sales of Humira® biosimilars has grown again. The latest biosimilar maker added to the list is Coherus Biosciences. Coherus has an investigational adalimumab biosimilar that completed a phase 3 trial in 2017 in patients with plaque psoriasis and psoriatic … Continue reading More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement →

A Profile of a Lesser-Known Player in the Biosimilar Space: Bio-Thera Solutions

On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a Guangzhou, China–based company, Bio-Thera Solutions. Established … Continue reading A Profile of a Lesser-Known Player in the Biosimilar Space: Bio-Thera Solutions →