FDA approves first Herceptin biosimilar from Mylan, Biocon
The Food and Drug Administration has approved the first biosmilar to treat HER2-positive breast cancer and certain gastric cancers, the agency announced Friday. Ogivri (trastuzumab-dkst), from Pittsburgh-based Mylan and Bengaluru, India-based Biocon, is a biosimilar of Genentech’s Herceptin, and the second biosimilar approved to treat cancer.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs,” FDA commissioner Scott Gottlieb said. “This is especially important when it comes to diseases like cancer, that have a high cost burden for patients. We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
The product is the first biosimilar approved under Mylan’s and Biocon’s joint portfolio in the United States, the companies said. The companies said Mylan expects to potentially be the first company to offer a Herceptin biosimilar, and that the approval clears a path for the company to commercialize the biosimilar in various global markets.
“The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system,” Mylan CEO Heather Bresch said. “Ogivri is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients.”
Biocon chief medical director Kiran Mazumdar said, “The U.S. FDA's approval for our biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients.”
OraSure partners with Walgreens to promote HIV testing
OraSure Technologies on Thursday announced several new HIV testing-related initiatives in recognition of World AIDS Day. OraSure is working with The AIDS Institute to launch a grant program to encourage the development of HIV self testing programs and collaborating with both The AIDS Institute and Walgreens, based in Deerfield, Ill., to promote rapid HIV testing in cities across the U.S.
Bethlehem, Pa.-based OraSure and Walgreens are launching the OraQuick In-Home HIV Test Retail Access Card, available for public health organizations and advocacy groups across the country to distribute to their at-risk program participants during outreach events. Each card will be redeemable for one OraQuick In-Home HIV Test kit at no cost, at any one of the 8,000+ Walgreens and Duane Reade drugstores nationwide.
“The Walgreens OraQuick HIV Test Retail Access Card will allow public health entities to utilize our expansive retail network to help get in-home HIV tests into the hands of customers who need one,” stated Glen Pietrandoni, senior director, patient care and advocacy at Walgreens. “In collaboration with OraSure, we are looking forward to working with Housing Works as well as other HIV/AIDS advocacy groups across the country as we continue to build on our 35-year history of community support in highly impacted communities.”
Initially, Walgreens and OraSure will provide the OraQuick In-Home HIV Test Retail Access Cards to Housing Works, a New-York City-based public health organization for people living with and affected by HIV/AIDS. And, in honor of World AIDS Day, OraSure, Walgreens and Housing Works will host a free HIV testing event on Dec. 1, from 11 a.m. until 4 p.m. EST at the Duane Reade located at 1430 Broadway in New York City. Free, OraQuick Advance HIV1/2 tests will be offered on a first come, first served basis as space and supplies permit.
"We are very proud to launch several programs aimed squarely at enabling HIV testing in support of World AIDS Day," stated Douglas Michels, president and CEO of OraSure Technologies. "A key challenge to ending HIV is to test as many individuals as possible who have not been previously tested so they can know their status and be linked to care."
In addition to supporting numerous community testing events across the country, OraSure will host the NASDAQ Stock Market Opening Ceremony followed by a special HIV testing industry panel discussion focused on Global Leadership in HIV Self-Testing: Innovative Approaches to Achieve HIV Testing Goals.
The panel discussion will be webcast live here starting at 10 a.m. EST on Dec. 1.
Guests for the NASDAQ market opening ceremony and panel discussion will include Karl Hofmann, president and CEO of Population Services International; Lelio Marmora, executive director, UNITAID; Jeffrey Klausner, professor Medicine and Public Health UCLA David Geffen School of Medicine and Fielding School of Public Health.
Trend toward self-management fuels growth of diabetes device sales
With the increasing trend of self-management and the rising awareness around the diabetes disease state within developing countries, blood glucose meters can be utilized to aid in adjustment of therapeutic regimen in response to blood glucose values and to help patients adjust their dietary intake, physical activity and insulin doses to improve glycaemic control on a regular basis.
This and several other factors are covered in the latest Research and Marekts report focused on diabetes care devices.
The global diabetes care devices market is expected to grow at a CAGR of 5.3% from 2017 to 2022 to reach $26.7 billion Research and Markets reported in its “Diabetes Care Devices Market – Global Opportunity Analysis and Industry Forecast (2017-2022)” report released Thursday.
Increasing prevalence of diabetes, technological advancements, rise in obese population, sedentary lifestyle and improper diet and increasing need for faster and safer diagnosis and treatment of diabetes are the key market drivers covered in the report.
However, high cost associated with diagnosis and treatment, reimbursement issues for new technologies and lack of awareness about the timely care of the disease for its better management are the major pain points, restraining the adoption of the diabetes care devices.