Frost & Sullivan: Global biosimilars space to reach $24 billion by 2019
LONDON — The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week.
Already, such Indian groups as Dr Reddy’s Laboratories, Biocon and Reliance Life Sciences are making a concerted effort to enter the European market, the report noted. Although these companies have not yet penetrated the European market, due to the stringent regulatory pathway, new product launches are expected in the mid-term.
Also, untapped U.S. markets with a strong biosimilars pipeline, as well as markets in Asia-Pacific and Latin America with a low cost of manufacturing, will afford key growth opportunities.
"On one hand, the market is powering ahead regarding the strength of participants’ global expansion strategies, and on the other, it is still beset by traditional patent-infringement issues," said Frost & Sullivan Healthcare senior research analyst Srinivas Sashidhar. "Moreover, the strategies adopted by innovator companies need to be taken into account. For instance, Johnson & Johnson has extended the European patent life of its innovator drug Remicade until February 2015, thereby delaying the launch of Hospira’s biosimilar monoclonal antibody (mAb) Inflectra and Celltrion’s biosimilar mAb Remsima."
To further reduce the time to market, companies should also explore opportunities in mergers and acquisitions and alliances with companies having expertise in biosimilars manufacturing and development, like Teva’s alliance with Cephalon and Lupin Pharmaceuticals’ alliance with Neuclone.
"In addition to mAbs, follitropins, interferons and low molecular weight heparins are likely to emerge in the long run," Sashidhar added. "However, some companies may focus on specific therapeutic classes depending on their capabilities and strategic fit."
CMS: ACOs generate $275 million in Medicare savings
WASHINGTON — Interim financial results for 114 ACOs that began work in 2012 show that they generated $128 million in savings for the Medicare trust fund in the first year, the Centers for Medicare and Medicaid Services reported in a blog posted Thursday. Additionally, initial results from an independent evaluation of 23 Pioneer ACOs, which are those that have more experience with coordinated care, show that they saved the Medicare program $147 million in their first year of operation.
"While still early in the program, with some ACOs making greater progress than others, the $275 million in savings — and the high quality of care that has accompanied it — are admirable results," CMS wrote. "ACOs are designed to achieve savings over several years, not always on an annual basis, but this is a very strong start. Moreover, through regular webinars, tools for sharing information and best practices, opportunities for ACOs to connect with one another and other activities, we’re providing ACOs the infrastructure and resources to learn from one another and to then diffuse what’s working and what’s not."
“Our experience has shown that ACOs can increase quality while lowering costs," said Kenneth Wilkins, president of Coastal Carolina Health Care. "As a result of the programs we’ve initiated, our patients have experienced better access to their primary care physician, higher quality measures and fewer trips to the hospital.”
Valeant approved for Retin-A Micro
LAVAL, Quebec — Valeant Pharmaceuticals International, a specialty pharmaceutical company, on Friday announced that it received approval from the Food and Drug Administration for Retin-A Micro (tretinoin) gel microsphere 0.08%, which is used for the topical treatment of acne vulgaris.
"We are very pleased that the FDA has approved our new strength of Retin-A Micro, as this gives healthcare providers and patients a new option for the topical treatment of acne vulgaris," J. Michael Pearson, chairman and chief executive officer, said. "This new strength will provide physicians and patients another effective treatment and should be a welcome alternative to current strengths. We look forward to launching 0.08% Retin-A Micro in the near future."