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Generics makers fight brand-name competition from "authorized" drugs
Washington, D.C.-The battle between pharmaceutical companies and generics makers is heating up, this time over increased moves by brand-name firms to put out their own low-cost "authorized" generic products. While this strategy undercuts the innovator's price, it probably hurts generics firms even more by greatly diminishing the value of the 180-day exclusivity period for the first generic to market.
WASHINGTON, D.C.-The battle between pharmaceutical companies and generics makers is heating up, this time over increased moves by brand-name firms to put out their own low-cost "authorized" generic products. While this strategy undercuts the innovator's price, it probably hurts generics firms even more by greatly diminishing the value of the 180-day exclusivity period for the first generic to market.
Brand-name firms have been making deals for authorized generics more frequently since enactment of the Medicare Modernization Act in 2003, which took steps to make it easier for generics to come to market. PhRMA (Pharmaceutical Research and Manufacturers of America) defends the authorized approach as a way to speed patient access to lower-priced drugs.
But the Generic Pharmaceutical Assn. (GPhA) recently retorted with its own analysis claiming that authorized generics actually raise drug costs. While the economists can debate the numbers endlessly, it's apparent that authorized generics can reduce the payoff for generics firms to seek early market entry. Generics makers have been willing to wage long and costly legal battles challenging innovator patents prior to expiration because of the prospect of a high reward: for 180 days the first firm can set a price slightly below the innovator and reap hefty profits. It usually is not until multiple generics competitors enter the market that innovator prices really tumble.
Sens. Jay Rockefeller (D-W. Va.) and Richard Schumer (D-N.Y.) are sponsoring a bill to ban authorized generics. Meanwhile, Congress has asked the Federal Trade Commission to examine how authorized generics affect prescription drug prices and competition.
A Conversation With Greg Baker, RPh, CEO of AffirmedRx
March 31st 2024Greg Baker, CEO of AffirmedRx, describes his early career, shares some of his critical opinions about the pharmacy benefit management (PBM) industry and how, in his view, his company is offering a better alternative.
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David Calabrese of OptumRx Talks New Role, Market Insulin Prices and Other Topics 'On His Mind'
April 13th 2023In this month’s episode of the "What's On Your Mind podcast," Peter Wehrwein, managing editor of MHE connects with the now Chief Clinical Officer of OptumRx Integrated Pharmacies, David Calabrese. In this conversation, David touches on his transition in January as OptumRx’s former chief pharmacy officer and market president of health plans and PBMs to his new role as Chief Clinical Officer where he now focuses more on things such as specialty pharmacy to home delivery — with an overall goal of creating whole-patient care. Throughout the conversation, Calabrese also touched on the market’s hot topic of insulin prices and behavioral health services within the OptumRx community, among other topics.
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Florida Gets the OK. But Will Drug Importation from Canada Actually Happen?
March 5th 2024Canadian health officials warn that maintaining a drug supply for Canadians is their priority. The staunch opposition of the U.S. pharmaceutical industry may also be an obstacle to imports from north of the border.
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Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
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What Payers Need to Know As Retail Pharmacies Move Into Primary Care
September 6th 2023Healthcare beyond the doors of the doctor’s office has the potential to offer more care to more people. But payers need to think about how to ensure that care is consistent. Regardless of the setting, care decisions must be based on evidence-based content and supported with strong patient education.
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