Inflation Reduction Act Targets Biologic Patents to Speed Biosimilar Savings

The Inflation Reduction Act could curb patent practices that delay biosimilar market entry by selecting drugs like Enbrel and Stelara for price negotiation.
Biologics account for a large portion of drug spending, so biosimilars can provide big savings, but originators use patent thickets to block competition.
Patent litigation has delayed many approved biosimilars from launching. Legislation to restrict patent practices has advanced but passage is uncertain.
In Europe, more biosimilars are approved and see faster, greater uptake due to purchasing practices favoring lowest cost.
U.S. originators have more leverage to block competition versus Europe, but the IRA's drug selections suggest a desire to accelerate biosimilar timelines.

forbes.com

Relevant topic timeline:

8/15/2023

Drug makers have tripled the prices of top Medicare drugs

Main topic: The exorbitant price hikes of the top 25 costliest drugs for Medicare Part D plans. Key points: 1. The price hikes of these drugs have more than tripled their list prices since entering the market. 2. The price increases far outstripped the rate of inflation, ranging from 20 percent to 739 percent. 3. Only one drug had price increases below the rate of inflation, while the average lifetime price increase for the top 25 drugs was 226 percent.

8/17/2023

Price gouging of cancer drugs in short supply hits some hospitals hard

Main Topic: Price gouging of cancer drugs during the drug shortage Key Points: 1. Smaller hospitals and cancer centers are facing price hikes of vital cancer drugs, with suppliers charging five to ten times more for medications. 2. Gray market vendors exploit drug shortages by buying medications at inflated prices and selling them to hospitals or clinics. 3. The increased costs pose a significant risk to cancer patients, especially those treated at smaller facilities with limited negotiating power and lower income levels.

8/29/2023

Biden administration names 10 prescription drugs for price negotiations

The Biden administration has identified 10 expensive prescription drugs, including blood thinners, diabetes treatments, and cancer drugs, for price negotiations with pharmaceutical manufacturers in an effort to reduce Medicare drug costs and ease the financial burden on beneficiaries, although the fate of the negotiation plan is uncertain due to ongoing lawsuits.

8/30/2023

Medicare should negotiate with drugmakers. But not set prices

The newly implemented rules in America that allow Medicare to negotiate drug prices could have damaging effects on innovation in the pharmaceutical industry and may discourage investment in new medicines, leading to fewer treatments in the future. Instead of focusing solely on price controls for drugs, regulators should address the issues within the rest of the supply chain, such as opaque middlemen and hospital mergers, to effectively lower healthcare costs.

9/14/2023

Medicare Begins Drug Price Negotiations, But Benefits Won't Arrive for Years

Summary: Medicare has started its first round of drug price negotiations, which is expected to benefit enrollees in the future, but immediate steps should be taken to lower medication costs.

10/16/2023

Pfizer Slashes COVID Vaccine, Treatment Sales Outlook; Cites 'COVID Fatigue' for Lower Demand

Pfizer's reduced sales forecast for its COVID-19 treatments and vaccines causes concern in the market, leading to a decrease in the stocks of its partners BioNTech and Moderna.

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Posted 10/2/2023, 4:08:35 PM