California will be the first state to develop its own low-cost drug analogues

California is poised to become the first state to develop its own line of generic drugs, targeting skyrocketing drug prices and entering a highly competitive market dominated by pharmaceutical companies with deep pockets. LA Times.

Photo: Shutterstock

On Monday, August 31, the Democratic-controlled state legislature overwhelmingly approved a measure requiring the state's leading health agency to partner with one or more pharmaceutical companies by January to manufacture and distribute a wide range of generic or biosimilar drugs, including insulin for treatment. diabetes, which will be cheaper than branded drugs.

SB-852 also opens the door for California to develop its own generic drugs in the future.

Governor Gavin Newsom will have to sign the measure or veto by September 30.

“People need these drugs, but the prices are through the roof, so we're saying it's the state's role to bring prices down,” said the bill's author, state Sen. Richard Pan (D-Sacramento).

The measure is more important than ever, he said, because COVID-19 has exposed “glaring gaps” in the ability of public and private entities, including large hospitals and government drug purchasers, to maintain adequate supplies of drugs, equipment and devices.

Democrat Newsom came up with his own generic drug proposal in January as part of his broader program to cut pharmaceutical costs, but was forced to abandon the plan in May as he and lawmakers sought to address the $ 54 billion budget deficit caused by the pandemic. ...

While it may take years to bring new California generics to market, the move will put the nation's most populous state in direct competition with major generic and brand-name drug manufacturers. It could also help the state use its huge purchasing power to lower drug prices.

Pharmaceutical Research and Manufacturers of America, representing branded drug manufacturers, took a neutral position on the bill and declined to comment.

But Brett Michelin, lead lobbyist for the Washington, D.C.-based Association for Affordable Drugs, which represents generic drug makers, said his companies are not threatened by California's entry into the market — and even welcomes the move.

“Generic drug manufacturers are more than open to this type of partnership,” Michelin said. “I think having a fair and open process for selling drugs and competing for customers is something the generic drug industry is very accustomed to.”

On the subject: How to save on prescription drugs without harm to health: a little-known way

Under the measure, generic drugs developed by the state would be “widely” available to public and private purchasers in California. Taxpayers will foot the bill—an estimated $1 million to $2 million to fund the startup, plus ongoing personnel costs estimated at several hundred thousand dollars annually, according to a state budget analysis.

It is unclear which drugs the state will manufacture or purchase, in general it is about drugs that can bring the greatest cost savings to the state and consumers. But the bill specifically calls for the production of "at least one form of insulin, provided that there is a viable way to produce a more affordable form of insulin at a cost that will lead to savings."

Insulin is a biological drug created from living cells. Once a biologic drug reaches the market, subsequent competing copycat products are called biosimilars.

Three major pharmaceutical companies—Eli Lilly and Co., Sanofi and Novo Nordisk—have long controlled the lucrative U.S. insulin market.

“California will be the first to produce a biosimilar version of one of the newer rapid- and long-acting insulins on a not-for-profit basis,” said Jane Horvath, a health policy consultant in Washington, D.C.

While it will be expensive and could take years, Utah-based nonprofit pharmaceutical company Civica Rx is discussing a partnership with California to produce generics or biosimilars. The company has already struck deals with major healthcare systems experiencing critical drug shortages, including the Department of Veterans Affairs, and produces low-cost generics for Blue Shield of California and other insurance companies.

“There is no doubt that developing insulin will be more complex and expensive, but it is certainly possible,” said Allan Kuckell, the company's senior vice president of public policy.

Patients requiring insulin faced a huge spike in costs. A 2019 report from the Institute for Healthcare Costs concluded that average insulin prices doubled from 2012 to 2016. Last year, California health insurance regulators found that diabetes drugs accounted for 9 of the 25 most expensive brand name drugs sold in the state.

“It's a big deal that diabetes affects many people who rely on insulin in their lives,” said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. “And insulin is probably an example of unreasonable drug pricing.”

Laura Marston, a Washington, D.C.-based diabetic lawyer who advocates lower prices for insulin, said she loved the California idea.

Marston has been taking the same insulin, Humalog, since 1996. At the time, the price per bottle was $ 21, but has since risen to over $ 275.

“If there was a cheaper option and the price wasn't going to go up, I would ditch Humalog completely,” she said. “I feel like a complete hostage to these pharmaceutical companies.”

Marston said she would like the federal government to do the same, and "that it applies to all patients."

Efforts by Congress to tackle rising prices of insulin and other drugs have failed in the past year due to opposition from the powerful pharmaceutical lobby. As such, states are increasingly looking for ways to regulate the commercial industry, in which brand-name manufacturers have near-monopoly power.

Colorado last year became the first state to limit cash payment for insulin at $ 100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing limits vary.

California has already capped out-of-pocket drug spending to $ 250 to $ 500 for a 30-day supply, but a measure that would bring the insulin limit down to $ 100 a month has stalled this year due to a shortened legislative calendar.

On the subject: In some US pharmacies, the margin reaches 840%: how to buy drugs cheaper

Newsom's office declined to comment on the generics law. But recent changes to the proposal reflect direct negotiations with the administration, Peng's office said.

Newsom spokesman Jesse Melgar said the Governor's "goal to create a sustainable universal coverage system has not changed, and making prescription drugs affordable is another step toward that goal."

If Newsom signs the bill, the state's Health and Human Services Agency will have 18 months to determine the list of drugs the state can produce, with a report due to the legislature by July 2022. By July next year, the state will have to assess the ability to manufacture its own generics and biosimilars.

The bill calls on state health officials to ensure first and foremost the development of generics for chronic and costly diseases, and the production of those drugs that can be delivered by mail.

California could lead the nation's drug debate, Levitt said.

“If California can pull this off, it will be a model for other states and the federal level,” he said. “This means it can be done on a large scale.”

Read also on ForumDaily:

Fires and hurricanes: how to prepare for an emergency evacuation

California Scientists Develop COVID-19 Protective Nasal Spray

How ideas about a healthy lifestyle have changed over the past 10 years

The collapse of confidence: why Americans are afraid of the COVID-19 vaccine

Do you want more important and interesting news about life in the USA and immigration to America? — support us donate! Also subscribe to our page Facebook. Select the “Priority in display” option and read us first. Also, don't forget to subscribe to our РєР ° РЅР ° Р »РІ Telegram  and Instagram- there is a lot of interesting things there. And join thousands of readers ForumDaily New York — there you will find a lot of interesting and positive information about life in the metropolis.