On November 2, the Biosimilars Forum released the results of a survey in an article titled “Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians,” published in Advances in Therapy. According to the abstract of the article, the survey was conducted from November, 2015, through January, 2016, and sought to assess…
Last Thursday, October 20, the FDA held a scheduled public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA). The FDA heard from a wide spectrum of stakeholders, including patient/public health advocates, healthcare professionals, and industry representatives. As we previously reported, the FDA had committed to publishing a draft…
The Economic Times of India has reported on a study of the Indian biosimilars market conducted by the Jawaharlal Nehru Institute of Advanced Studies (JNIAS). The study reports that the Indian biosimilars industry was close to $300 million in 2015, with domestic sales accounting for $250 million growing at a…
On October 6-7, 2016, the Medicare Payment Advisory Commission (MedPAC), a federal agency that advises Congress on Medicare pay policies, held a public meeting, with one session titled “Biosimilars in Medicare Part D.” This session concerned, among other things, market acceptance of biosimilars, including issues relating to interchangeability and costs. …
As Congress pressures manufacturers to move biosimilars to market more quickly and the need for lower priced prescription drugs increases, there is a concern that public trust in the safety and efficacy of these new drugs could suffer. However, PharmExec.com reported that a Sanford C. Bernstein financial analyst was optimistic…
Big Molecule Watch is here to keep you up to date with conferences near and far. Biosimilars Congress India 2016 will take place in Hyderabad, India from October 13-14th. Registration is open and you can even request the proposed agenda ahead of time. The 6th International Conference and Exhibition on…
Precision for Value evaluated various considerations that factor into the level of biosimilars uptake, focusing primarily on Europe’s recent introduction of biosimilar anti-tumor necrosis factor drugs (anti-TNF drugs). Amongst its findings, the authors discovered that discounts do not correlate to the level of biosimilar uptake, and that factors such as…
In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an interchangeability between biosimilars and their reference tumor necrosis factor-α (TNF-α) inhibitor counterparts. While this study only…
Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has been approved by the FDA to be an interchangeable biological product. Missouri is now the twenty second state…
Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and American health systems up to $110 billion by 2020. The current report discusses the expected changes to…