Tag

Biosimilars

All articles tagged with #biosimilars

health2 months ago

FDA Accelerates Generic Biologic Approvals to Reduce Drug Costs

The FDA announced plans to accelerate the approval process for generic biologic medicines, or biosimilars, to increase competition and reduce high drug prices in the U.S., which are significantly higher than in other countries. The reforms aim to cut the approval timeline in half, simplify studies, and remove barriers to market entry, potentially saving billions in healthcare costs and providing more affordable options for patients.

business-and-finance2 years ago

CVS Shifts From Humira to More Affordable Biosimilars, Impacting AbbVie Sales

Abbvie's stock price experienced a significant drop after CVS Health announced it would no longer cover the pharmaceutical giant's blockbuster drug, Humira, opting instead to support biosimilar alternatives. This move by CVS is expected to have a notable impact on Abbvie's revenue, as Humira has been one of its top-selling drugs. Investors reacted to the news, leading to a decline in Abbvie's shares during extended trading.

business2 years ago

AbbVie Stock Beats Expectations Despite Revenue Decline

AbbVie reported second-quarter earnings and revenue that were lower than the previous year but exceeded expectations. The company's earnings per share came in at $2.91, down 13% from the same period last year, while revenue fell 5% to $13.86 billion. Analysts had predicted earnings of $2.83 per share on revenue of $13.54 billion. AbbVie's stock rose 5.4% following the announcement. The company is facing challenges from biosimilar competitors to its drug Humira but is seeing growth in sales of its newer immunology drugs Rinvoq and Skyrizi, as well as its schizophrenia treatment Vraylar.

healthcare2 years ago

Yusimry's Competitive Pricing Poses Threat to Humira in Health Market

AbbVie's blockbuster drug Humira, which has been the world's best-selling drug for many years, is now facing competition from lower-cost copycats known as biosimilars. Humira, with a list price of nearly $7,000 a month, treats various illnesses but has been protected by patents. However, disputes over patents have finally allowed nine Humira biosimilars to enter the market. Despite the availability of these lower-priced alternatives, the complex pharmaceutical system, including pharmacy benefit managers and insurance coverage, has hindered their adoption. A new biosimilar called Yusimry, priced at about $1,000 a month, is being sold by Coherus BioSciences and could potentially break through due to its significantly lower cost, potentially leading to savings for insurance plans and patients.

health2 years ago

The Safety and Effectiveness of Biosimilars in Psoriasis Treatment

A systematic literature review published in JAMA Dermatology has found that biosimilar drugs are safe and effective in treating psoriasis. The analysis compared approved biological drugs with their biosimilar counterparts and found no clinically meaningful differences in efficacy and adverse events. Despite the potential advantages of biosimilars, such as easier access to innovative therapies and cost savings, doctors and patients have been slow to accept them. However, the future direction of biosimilars looks promising, with the potential for wider use outside of hospital reference centers. The study authors recommend considering biosimilars alongside originators to improve accessibility to biological treatments and suggest that switching from originator to biosimilar could be assessed to reduce treatment costs.

business2 years ago

AbbVie Stock Struggles Amid Humira Patent Expiration and Underperforming Drugs.

AbbVie's stock fell 8.5% after the first approved biosimilar copycat to launch in the US, Amgen's Amjevita, hammered away at Humira's legendary sales, which slumped more than 25% to $3.54bn. AbbVie's newer immunology drugs, Skyrizi and Rinvoq, missed sales forecasts, but the company still expects both drugs to contribute a combined $11bn to sales this year. AbbVie has focused on next-generation immunology treatments Skyrizi and Rinvoq to contend with Humira's downfall.

healthcare2 years ago

Medicare unveils new drug pricing guidelines and penalties for manufacturers.

The Centers for Medicare and Medicaid Services (CMS) has released new guidance outlining its criteria for negotiating drug prices for Part D beneficiaries. The guidance includes details on which drugs would qualify, with biosimilars and original brands for biosimilars excluded, and a resolution process for disputes. The agency will first identify the top 50 most expensive drugs to Medicare and then whittle down to the top 10 based on various criteria. The first 10 drugs to be negotiated will be revealed in September, with public input accepted until April 14. Experts have mixed reviews about the guidance, with some calling it a White House public relations stunt and others impressed with the depth of detail provided.