GPhA establishes new division in Biosimilars Council
WASHINGTON — The Generic Pharmaceutical Association announced Thursday the launch of the Biosimilars Council, a division of GPhA.
“Following unanimous Board of Directors’ approval, the Biosimilars Council is the culmination of the Association’s longstanding and unwavering commitment to patient access to safe, affordable and lifesaving biosimilar medicines," stated Craig Wheeler, GPhA board chairman and president and CEO of Momenta Pharmaceuticals. "The GPhA Biosimilars Council is designed to meet the unique needs of healthcare companies as they navigate this emerging space,” he said.
“In addition to being a voice with policymakers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars,” Wheeler said. “The GPhA Biosimilars Council also will be a key resource for organizations seeking relationship building opportunities, and a forum for indepth scientific, regulatory, legislative and policy discussions.”
The Biosimilars Council will comprise manufacturers and stakeholders working to ensure a positive regulatory, reimbursement, political and policy environment that supports patient access to these more affordable new medicines. The Biosimilars Council also is the industry’s first educational resource for the general public and patient groups seeking information about the safety and effectiveness of biosimilars.
Among the first offerings of the Biosimilars Council is a new educational handbook, "The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products." This publication explains the benefits and science behind biosimilar medicines — safe, effective alternatives to costly biologic therapies. It explains who will benefit from access to these medicines, outlines the legal and regulatory framework, and illuminates the quality manufacturing and development process in approachable language.
The GPhA Biosimilars Council will begin operations immediately. As per recently adopted changes to the GPhA bylaws, a Biosimilar board, elected by members of the Biosimilars Council, will develop the Association’s biosimilar activities and programming consistent with the longstanding mission of GPhA and the association’s board of directors. With a roster of committed members and full startup funding, the new division will supplement GPhA’s regulatory, government affairs, policy and communications/education team to support anticipated activities. The GPhA Biosimilars Council will welcome all biosimilar companies dedicated to bringing more affordable biosimilar medicines to US patients as it works to continue its leadership in supporting this emerging industry.
“GPhA and its members historically have been the industry pioneers on biosimilars, beginning with their role as the fundamental organizing force behind the law which created the biosimilar pathway. The Biosimilars Council is the next evolution in this leadership, and will ensure these new medicines will deliver tremendous benefits for both our health and our healthcare system,” said GPhA president and CEO Ralph Neas. “We look forward to continuing to work with our strategic partners and all stakeholders who share our vision of the transformative potential of biosimilars and interchangeable biologics.”
Sandoz introduces generic Copaxone to treat MS
HOLZKIRCHEN, Germany – Sandoz, a Novartis company, on Thursday announced the U.S. approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml one-time-daily multiple sclerosis therapy.
"Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy," stated Peter Goldschmidt, president of Sandoz US. "The approval of Glatopa reinforces Sandoz leadership in complex, differentiated generic products and further demonstrates our commitment to offer patients and payors a full range of therapeutic options."
MS is a debilitating disease affecting about half a million individuals in the U.S. alone; only half of those diagnosed are currently treated.
Glatopa, developed in collaboration with Momenta and produced entirely in the U.S., is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.
Corlanor from Amgen granted FDA approval
BY Ryan Chavis
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced approval for Corlanor (ivabradine) for use in certain patients who have chronic heart failure.
According to the FDA, heart failure is a common condition that affects close to 5.1 million people in the United States. The condition arises when the heart cannot pump enough blood to meet the body’s needs. Heart failure worsens over time as the organ’s pumping action grows weaker. Coronary heart disease and high blood pressure are leading causes of heart failure, the FDA said.
“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.”
Corlanor was granted priority review by the FDA, which expedites the review process for drugs that are indicated to treat serious disease and conditions and may provide significant improvements over therapies that are currently available. The drug is produced by Amgen.
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