In reaction to the tumult over high insulin prices, the Food and Drug Administration (FDA) has been firming up its plans for a transition to biosimilar competition for insulin. Lilly, one of the dominant insulin manufacturers in the US, has decided to cut prices through the authorized generic route. In this case, a manufacturer that … Continue reading Lilly to Launch Authorized Generic for Humalog
Tag: rebates
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?
Biosimilars and Drug Rebates: A Foot in the Door to Access?
At the September 5–7, 2018 GRx+Biosims meeting, I had the opportunity to moderate a session with three highly experienced biosimilar industry executives. They included Gary Deeb, Senior Vice President, Global Licensing and Business Development, Lupin Pharmaceuticals; Chrys Kokino, MBA, Head Global Biologics— Commercial, Mylan; and Mike Woolcock, MBA, Senior Vice President, Commercial Operations, Apobiologix. In … Continue reading Biosimilars and Drug Rebates: A Foot in the Door to Access?
Anti-kickback Safe Harbors, Drug Rebates, Biosimilars, and FDA
Over the next couple of weeks, I’ll be issuing a series of posts to further analyze some of the Food and Drug Administration’s (FDA’s) new Biosimilars Action Plan. Outside of patent litigation, the greatest barrier to biosimilar access is the current drug rebate contracts agreed to by pharmaceutical companies, health plans, and pharmacy benefit managers … Continue reading Anti-kickback Safe Harbors, Drug Rebates, Biosimilars, and FDA
How Will Biosimilars Be Affected by Trump’s Drug Price Reform Measures?
When President Trump announced the broad strokes of his drug price reform initiative, some of these measures seemed on target to benefit the biosimilars industry. However long awaited, makers of originator biologics seemed not to be worried about its implications. The President may not be able to effect much change, without causing unintended adverse consequences. … Continue reading How Will Biosimilars Be Affected by Trump’s Drug Price Reform Measures?
Lessons for Biosimilars From the Generic Drug Industry
The utilization of generics in the US is vast, upwards of 86% of all prescriptions in 2017, according to the latest research by IQVIA. The pace of generic drug approvals by the Food and Drug Administration is also impressive, with 767 last year. This does not ensure the future of the generic drug industry, however, … Continue reading Lessons for Biosimilars From the Generic Drug Industry
FDA’s Gottlieb to Health Plans: Move Away From Short-Term Rebates on Reference Drugs to Enhance Long-Term Biosimilar Savings
According to Food and Drug Commissioner Scott Gottlieb, MD, the managed care sector’s willingness to accept larger rebates from manufacturers of originator biologics to preserve formulary coverage may seriously hinder the long-term success of the biosimilar industry. And more importantly, the ability to control biologic costs through competition. In remarks made to a national meeting … Continue reading FDA’s Gottlieb to Health Plans: Move Away From Short-Term Rebates on Reference Drugs to Enhance Long-Term Biosimilar Savings
What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
AbbVie executives are sticking to their pledge to restrict annual price increases on Humira® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market. In 2023, when adalimumab biosimilars become available, the savings biosimilars represent may not be real savings at all. Pharmaceutical companies generally seek to … Continue reading What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
Is There an Escape From the Rebate Trap?
The rebates given to pharmacy benefit managers to secure a drug’s place on the formulary have become a difficult barrier to coverage for new products. The rebate income for these PBMs is sometimes passed on to health plans, insurers, and employer purchasers, but more often it is not. A big issue is that managed care … Continue reading Is There an Escape From the Rebate Trap?
Pfizer Sues J&J on Anticompetitive Practices on Infliximab in the US
Whereas Pfizer has made some inroads to the US market, since its launch at the end of 2016, Janssen has done a good job of blocking and tackling—playing the contracting game. The lawsuit claims that Janssen has withheld or threatened to withhold rebates if payers do not keep Remicade in an exclusive preferred position.