Drugs

Pfizer Says J&J Illegally Blocking Remicade Competition

Pfizer has filed suit in Pennsylvania federal court against Johnson & Johnson and its Janssen Biotech unit for antitrust violations in blocking competition from Pfizer’s biosimilar Inflectra (infliximab-dyyb) to protect Janssen’s Remicade (infliximab). The suit says the case is about J&J “imposing a web of exclusionary contracts on both health insurers and healthcare providers (e.g., hospitals and clinics) to maintain its stranglehold in respect of an important biologic, brand name Remicade, also known by its generic name, infliximab.”

The filing says that between 1998 and 2016, Remicade was the only infliximab product on the market. It generated about $4.8 billion in sales for J&J in 2016 alone, it says, with a list price of about $4,000 per infused dose and $26,000 for a full year of treatment. “When Pfizer introduced its competing biologic Inflectra in 2016,” the suit contends, “J&J deployed improper exclusionary tactics to maintain the dominance of its flagship product.”

According to Pfizer, J&J deployed what it publicly termed its “Biosimilar Readiness Plan” centered on exclusionary contracts that foreclose Pfizer’s access to an overwhelming share of consumers, coupled with anticompetitive bundling and coercive rebate policies designed to block both insurers from reimbursing and hospitals and clinics from purchasing Inflectra or other biosimilars of Remicade, despite their lower pricing.

Pfizer asks the court for treble monetary damages in excess of $150,000, costs of the suit including attorney fees, a declaration that J&J’s conduct is unlawful, appropriate preliminary and permanent injunctive relief barring J&J from continuing to undertake its anticompetitive scheme, including the exclusionary contract, and other relief decided on by the court.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome