Insulin Glargine(Mylan Nv)

The proposed legislation, which was reintroduced on June 4 by Sen. Mike Lee aims to remove the distinction between biosimilars and interchangeable biosimilars. As biosimilars struggle to live up to their promise of cutting costs and improving access to biologic medicines for U.S. patients, more than 39 advocacy groups are championing recent bipartisan efforts to cut through the bureaucracy that they believe has kept adoption at bay.The Association for Accessible Medicines (AAM) and the Biosimilars Council, alongside a clutch of advocacy organizations and healthcare provider groups like Public Citizen, the Academy of Managed Care Pharmacy and the Blue Cross Blue Shield Association, have voiced their support for the Biosimilar Red Tape Elimination Act in a letter sent (PDF) Tuesday to leaders of the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP).The proposed legislation, which was reintroduced on June 4 by Sen. Mike Lee, aims to remove the distinction between biosimilars and interchangeable biosimilars. The bipartisan bill was co-sponsored by Sens. Rand Paul, Maggie Hassan and Ben Ray Luján.“Interchangeability is a designation that doesn’t exist anywhere else in the world and there is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” John Murphy III, president and CEO of AAM, said in a release detailing the HELP committee letter. “The number of groups who’ve joined us in support of this bill shows how impactful cleaning up this confusion will be for patients.”Biosimilars are effectively just generic versions of biologic drugs, and a biosimilar that boasts an interchangeability tag can be substituted for the reference drug right at the pharmacy counter without additional doctor signoff.That said, the implementation of interchangeability in the U.S. market—which kicked off with the approval of Biocon and Viatris’ interchangeable insulin biosimilar Semglee in 2021—could be muddling treatment decisions and hampering uptake of the lower-cost medicines in the process, the Biosimilars Council, AAM and their co-signers wrote in the letter.By eliminating what the letter argues is an arbitrary distinction, the Biosimilar Red Tape Elimination Act would increase access to biosimilar drugs and reduce overall healthcare costs from branded biologics, the co-signers argued.Still, some groups within the industry are less eager to loosen restrictions around biosimilars. The Biosimilar Red Tape Elimination Act marks a "concerning departure" from the standards currently in place, Andrew Powaleny, spokesperson for the pharmaceutical industry trade group PhRMA, said in an emailed statement. "The bill would do away with important safeguards that protect patient safety without addressing the anticompetitive behavior by pharmacy benefit managers that block access to biosimilars and allow them to profit from medicines at the expense of patients," he argued. Biosimilars first hit the market in the U.S. in 2015 and have since generated savings of more than $36 billion in their use across more than 2.6 billion days of patient therapy, all while demonstrating no clinically meaningful differences in patient safety or health outcomes versus their reference drugs, according to AAM and the Biosimilars Council.Nevertheless, biosimilars have consistently struggled to gain traction in the U.S. when compared to the European market, despite the long-held expectation that they could lower costs and improve biologics access for American patients by increasing market competition, according to an article published last year in the American Journal of Managed Care (AJMC).The FDA was already well aware of the problem in 2019 when it released a report highlighting that U.S. biosimilar market share was lagging significantly behind trends seen in Europe. At the time, the regulator pinpointed several factors that may have contributed to sluggish biosimilar uptake, including reimbursement hurdles and a lack of interchangeability data.Aside from economic constraints, multiple industry watchers have pointed to the toll that interchangeability designations and other perception problems around biosimilars could be taking on their adoption in the U.S. By suggesting that only certain biosimilars are interchangeable with their reference drugs, the designation could imply—to both patients and doctors—that non-interchangeable biosimilars “might not meet safety or efficacy standards,” AJMC affiliate The Center for Biosimilars pointed out in an article on biosimilar use in oncology last summer.“The FDA has made clear that this arbitrary designation creates confusion, and that scientifically, biosimilars and interchangeables are not distinguishable,” Giuseppe Randazzo, SVP of sciences and regulatory affairs at the Biosimilars Council and AAM, said in Tuesday’s press release.AAM and the Biosimilars Council’s letter—which also included signatures from groups like Kaiser Permanente, the Allergy and Asthma Network and pharmacy benefit manager Prime Therapeutics—was addressed to Sens. Bill Cassidy, M.D., and Bernie Sanders, who serve as chair and ranking member of the Senate Health Committee, respectively, plus representatives Brett Guthrie and Frank Pallone. Sen. Lee originally introduced his biosimilar legislation in November 2022 in a bid to eliminate FDA requirements for switching studies—wherein patients alternate between a biosimilar and its reference biologic—to obtain interchangeable status and effectively make all approved biosimilar drugs interchangeable.“Our regulatory environment is making it too difficult and expensive for biosimilars to make it to the market,” Lee said at the time. “It’s the patients who suffer from a lack of competition and high drug prices.”Editor's note: This story has been updated with a statement from PhRMA. 

Bengaluru: Biocon Biologics insulin supply contract to Malaysia has been extended by the country’s health ministry by six months, till October this year. “The Government of Malaysia has agreed to extend the insulin supply agreement's current contract period of 36 months for an additional six months effective from “April 29, 2025 until October 28, 2025,” the company announced in a stock exchange filing. “Amendment to the contract will be formalised through the execution of a formal supplementary agreement between the MoH, DMktg and Biocon subsequently,” it added. The company was awarded the insulins supply contract for a three-year period in 2022, valued at $90 million (around ₹760 crore), for its recombinant human insulin brand Insugen . The contract is jointly held by the Indian drugmaker Malaysian subsidiary Biocon Sdn. Bhd, and Duopharma Marketing Sdn. Bhd. (DMktg) and under the terms of agreement, the drug is manufactured and supplied by Biocon and its contract partner DMktg, a domestic biotech player looks after the distribution, according to a release from Biocon issued when the contract was awarded. The supplied Insugen formulations are available to patients at the country's all Ministry of Health hospitals, district health offices and health clinics, the release added. Biocon has a recombinant human insulin production facility and a Center of Excellence (CoE) for insulins in Malaysia and the drugmaker has been operating in the country for the last 10 years. In September 2021, Biocon Biologics’ Basalog (biosimilar Insulin Glargine) was awarded a multi-ministry pooled tender worth $4.2 million (around ₹36 crore) by MoH, Malaysia for a period of two years. By Online Bureau ,