FDA releases draft guidance for biosimilars
SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.
The Patient Protection and Affordable Care Act of 2010 contained a provision for an abbreviated regulatory approval pathway for biosimilars, but the task of creating regulations for them was left to the FDA itself. The guidance documents released Thursday include scientific considerations for helping companies demonstrate that a proposed biosimilar is similar to the original branded version, quality considerations for demonstrating biosimilarity and a document with common questions and answers.
"When it comes to getting new biosimilar products on the market, [the] FDA has taken an innovative approach to supporting their development at every step of the pores," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "These draft documents are designed to help [the] industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
The generic drug industry, which has long pushed for a biosimilar pathway, praised the release of the draft guidance. "GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients," a statement released by the Generic Pharmaceutical Association read.
FDA approves Mylan antimicrobial drug
PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.
The FDA approved Mylan’s doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott’s Doryx.
Warner Chilcott launched a patent infringement suit against Mylan in the U.S. District Court for the District of New Jersey in response to the latter’s filing for FDA approval of the drug. The court is expected to reach a decision in March, and Mylan said it agreed not to launch the drug until then, though it expected to be the first to launch a generic version.
Doryx had sales of about $264.1 million in 2011, according to IMS Health.
CVS offers health screenings, pharmacist Facebook chat for American Heart Month
WOONSOCKET, R.I. — Recognizing that cardiovascular disease affects about 80 million people in the United States and is the No. 1 killer of Americans, CVS/pharmacy announced on Thursday that it is providing several free services, educational information and special product offers during February’s American Heart Month.
As part of its new Project Health wellness and free health screenings program, CVS/pharmacy will provide free blood pressure, cholesterol, body mass index and osteoporosis screenings every weekday in February from 3 p.m. to 7 p.m. at select CVS/pharmacy locations in Atlanta; Chicago; Dallas-Fort Worth; Detroit; Houston; Los Angeles; Miami; New York; Philadelphia; Washington, D.C.; and Puerto Rico.
As previously reported by Drug Store News, CVS/pharmacy’s Project Health will deliver more than $21 million worth of free health screenings to multicultural communities this year to help prevent disease through early detection. More than 1,000 Project Health events will be held during five disease-specific national health awareness months, including Heart Health Month.
To further help patients by answering their questions about heart health and managing cardiovascular disease, CVS/pharmacy will host a live Facebook chat with a CVS pharmacist on Feb. 15 from noon to 1:30 p.m. The live online event will be free and open to the public, and can be accessed by logging on to the CVS/pharmacy Facebook page.
"As a pharmacy innovation company, we are pleased to provide free resources, such as Project Health screenings and an online pharmacist chat, to help people on their path to better health during American Heart Month," stated Papatya Tankut, VP pharmacy professional services at CVS/pharmacy. "In addition to these programs, CVS pharmacists are always available to support their patients’ heart health by counseling them on ways to lower prescriptions costs, manage their medications and improve medication adherence in order to achieve better health outcomes."
In further recognition of American Heart Month, CVS/pharmacy will provide healthy savings and tips through its 2012 Heart Smart Guide, which is available at select locations across the United States in February. The guide contains information about recognizing the signs of a heart attack, monitoring your blood pressure, cholesterol, blood sugar and weight, and advice on eating smart and staying active. It also features savings offers on heart-healthy products available at CVS/pharmacy.
Even more product savings are available through CVS/pharmacy’s ExtraCare Advantage for Diabetes program. Members will receive an at-home mailing in February that contains more than $100 in savings on diabetic and heart-health products at CVS/pharmacy. ExtraCare Advantage for Diabetes helps patients with diabetes keep costs down on an ongoing basis throughout the year with discounts on hundreds of supplies to help them successfully manage their condition.