Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab. According to Pfizer's Director of Global Media Relations, Thomas Biegi, the company had submitted two applications for this biosimilar, one for a limited set of indications, and the other for … Continue reading Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
Tag: Humira
United Kingdom to Save 75% on Annual Humira Spending
Since the October expiration of Abbvie's EU patent, the potential Humira savings seem to be truly mind-blowing. After implementing its contracts for adalimumab, the UK National Health Service (NHS) should save about three quarters of the $514 million (£400 million) it spends each year on this product alone. In a fixed-budgeted system like that in the … Continue reading United Kingdom to Save 75% on Annual Humira Spending
Abbvie’s Humira Price Cuts Don’t Win the Business in Denmark
Just a few short weeks ago, Abbvie announced that it intended to rely on discounts as deep as 80% in parts of the EU to retain Humira® marketshare. One bellweather EU member country has signaled that it is signing tenders with other biosimilar adalimumab manufacturers. The Center for Biosimilars reported an Email exchange with the … Continue reading Abbvie’s Humira Price Cuts Don’t Win the Business in Denmark
Momenta Signs Licensing Deal With Abbvie. Did It Have a Choice?
We previously reported that Momenta Pharmaceuticals reevaluated its biopharmaceutical strategy going forward, deciding to move forward only with its investigational adalimumab and aflibercept biosimilars. Yesterday, Momenta announced that it has joined the long queue of pharmaceutical manufacturers signing a biosimilar licensing deal with Abbvie, which will allow commercialization of M923, its biosimilar to Humira, should … Continue reading Momenta Signs Licensing Deal With Abbvie. Did It Have a Choice?
A Third Biosimilar Adalimumab Approval in the US and Potentially Huge Humira Price Discount in Europe
The Food and Drug Administration (FDA) announced yesterday the approval of adalimumab-adaz from Sandoz. The new agent, dubbed Hyrimoz™, will not be launched in the US until 2023. The approval of Hyrimoz is the third for Sandoz (but only one, Zarxio®, is available for prescription in the US). The FDA approval of adalimumab-adaz covered several … Continue reading A Third Biosimilar Adalimumab Approval in the US and Potentially Huge Humira Price Discount in Europe
Biosimilar Step Therapy for Medicare Part B: Does This Make Sense?
The Centers for Medicare and Medicaid Services (CMS) has decided drugs covered under Medicare part B may be subject to step therapy, if so desired by Medicare Advantage plans. UnitedHealthcare has become the first to publicly implement step therapy policies for these drugs. However, biosimilar step therapy is not the typical utilization management tool that … Continue reading Biosimilar Step Therapy for Medicare Part B: Does This Make Sense?
Pfizer’s Anticompetitive Suit: A Slippery Slope to Competitive Bidding?
When Pfizer first announced its lawsuit against Janssen’s parent Johnson & Johnson in September 2017, it pointed to exclusionary contracting, “anticompetitive" behavior of Remicade®’s maker as the reason for its very limited market access. The lawsuit claimed that Janssen has withheld or threatened to withhold rebates if payers do not keep Remicade in an exclusive … Continue reading Pfizer’s Anticompetitive Suit: A Slippery Slope to Competitive Bidding?
Mylan Rethinking Its US Business Strategy?
In reporting lower earnings on its second-quarter revenues, Mylan may have surprised industry observers by offering the possibility of some changes in strategic direction. Although Mylan executives sounded hopeful notes on the company’s biosimilar portfolio, the hints CEO Heather Bresch provided may affect the marketing of the biosimilars as well as its other pharmaceutical business. … Continue reading Mylan Rethinking Its US Business Strategy?
Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it. Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not … Continue reading Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
Let’s not Knock Innovation, but Biosimilars Exist for the Sake of Competition
A recent Twitter conversation between a blogging colleague of mine and a German advocate of precision medicine propelled this post: What is the real benefit of biosimilars? Does biosimilar development detract from efforts to produce innovative medicines? Is the main societal benefit biosimilar cost savings? Biosimilar Development Is Separate From Innovation Development The main reason … Continue reading Let’s not Knock Innovation, but Biosimilars Exist for the Sake of Competition