All articles tagged with #biosimilars
Trump’s drug-pricing efforts have yielded uneven gains: Medicare's negotiated discounts cut some prices and cap out-of-pocket costs, and TrumpRx offered notable cuts on certain brand drugs, but overall about 1,000 branded drugs rose in price in early 2026, and benefits mostly reach cash-paying patients, with many discounts opaque and limited in scope; experts say the policy changes do not broadly reshape drug pricing.
Sun Pharmaceutical Industries to acquire Organon & Co. in an all-cash deal worth an $11.75 billion enterprise value, at $14 per Organon share. The transaction requires Organon stockholder approval and regulatory clearances and is expected to close in early 2027. The combined entity would be a major global pharma player with strengthened capabilities in established brands/branded generics, biosimilars, and women’s health, while expanding Sun Pharma’s footprint in innovative medicines.
At its March 2026 meeting, the EMA CHMP recommended five medicines for approval (Adstiladrin, Imdylltra, Joenja, Zepzelca, Bopediat), plus extensions of indication for 13 other medicines. It upheld its previous decision to refuse a change to Hetlioz’s marketing authorisation and noted withdrawal of Blarcamesine Anavex. In the Tecovirimat SIGA case, the committee concluded it should no longer be used for mpox. Other updates include a new subcutaneous route for Sarclisa and a biosimilar development reflection paper. The agenda and minutes will be published by EMA in coming weeks.
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.
The FDA announced new measures to streamline the approval process for generic biological drugs, or biosimilars, aiming to reduce development costs and accelerate market entry, ultimately lowering drug prices and increasing access for Americans.
The FDA announced new measures to streamline the development and approval of biosimilar drugs, aiming to lower costs and increase access to affordable biologic treatments by simplifying testing requirements and promoting interchangeability, thereby fostering market competition and reducing healthcare expenses.
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.
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.
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.
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.
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.
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.