Va. governor signs first state bill to limit biosimilars
WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.
McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.
It would also require the pharmacist to inform the patient before dispensing and record the name of the product and its manufacturer on the dispensing record and prescription label. In addition, pharmacists would be required to provide cost information for the reference product and the biosimilar to the patient.
While praising the bill’s sunset clause, saying it meant the bill would likely expire before any Food and Drug Administration-approved biosimilar became available, the Generic Pharmaceutical Association, a trade group that represents generic drug companies, criticized the bill.
“The law signed today in Virginia to allow for the substitution of biosimilars in that state, while well intentioned, is pre-emptive, and carries burdensome administrative ‘red tape’ that threatens the positive impact biosimilars will have in Virginia," GPhA president and CEO Ralph Neas said.
Similar laws have been working their way through the legislatures of other states, such as Colorado and Florida, and could stand in the way of full implementation of the biosimilar approval pathway that passed as part of the Patient Protection and Affordable Care Act. While the healthcare-reform law created the conditions for an abbreviated pathway for biosimilars, similar to the one created for generic drugs with the Hatch-Waxman Act of 1984, it is up to the FDA to create the specific regulations, which the agency is still in the process of doing.
Biotech companies have supported the state laws, saying they are necessary to promote patient safety. They say that unlike generic drugs, which are required to be identical to their branded counterparts, slight changes to a biologic drug — such as generic differences between the cell lines used by the creator of an original biologic and those used by the creator of a biosimilar — can dramatically change its properties and therefore its safety and efficacy profile.
But generic drug companies, which strongly backed the abbreviated pathway for biosimilars, dispute the biotech industry’s view.
"The push for these new measures has nothing to do with safety and everything to do with Amgen and Genentech, two biotech Goliaths, trying to thwart competition," Neas said.
Walgreens debuts flagship location in Washington, D.C.’s Chinatown
WASHINGTON — On Thursday morning, Walgreens opened the doors to its latest flagship location in the nation’s capital, bringing to District of Columbia residents and commuters the kind of retail pharmacy theater already familiar with citizens of New York, Chicago and Los Angeles.
Specifically, the seventh Walgreens flagship is located at the entrance to Washington’s downtown Chinatown district. The exterior facade features a "Walgreens" sign with Mandarin and Chinese characters that translate as "pharmacy." It’s located just outside the subway hub of Gallery Place, where the red, green and yellow lines all intersect and just one stop from the National Mall and most of the federal buildings. It’s a popular lunch and dinner destination, and home to much of the D.C. night life. And it’s where the magic happens. Literally. The arena where the Washington Wizards play is just down the street.
A 24-hour location, the new Walgreens encompasses three floors covering some 21,000 sq. ft. of space that is defined by Walgreens’ fresh offerings on the main floor, health one floor below and beauty one floor above. And there is a D.C. flavor throughout. Items on the juice menu are full of capital references like the bi"pear"tisan, georgetown juice and the west wing watermelon. Over by the escalators is a wall of state names, or local street names, depending upon your point of view. There also is a Coca-Cola Freestyle machine dispensing 130 varieties of Coca-Cola fountain drinks and an Upmarket Café offering a barista preparing fresh brewed premium coffee and espressos.
Overhead at the entrance to the beauty floor is an homage to the Capital Rotunda. And the wrought-iron "Look Boutique" signage is fashioned after the White House entrance gate. Also on the second floor, the newest Washington, D.C., location is home to the second full-line display of Alliance Boots’ No7 prestige beauty brand. (The first is in Los Angeles.)
Specially trained beauty advisers are on hand to offer guidance finding the best solutions for individual needs, including a Gosh Cosmetics lip applicator equipped with a light and mirror that will be ideal for women on their way to a nearby nightclub.
And Walgreens’ Nail Bar will offer professional manicures with the latest colors from essie and OPI at $12. Expert shaping and grooming services will be available at the Eyebrow Bar.
On the lower floor, Walgreens features its latest pharmacy floor plan that’s designed to encourage greater interaction between pharmacists and patients. An iPad-equipped health guide will be there to help pharmacy customers navigate health-and-wellness products, as well as identify services and resources, including immunizations and health tests. The pharmacy also features an “Ask Your Pharmacist” desk, consultation rooms and Express Rx kiosks for swift checkout.
A Take Care Clinic offering a wide range of healthcare services is adjacent to the pharmacy. Aligned with the store opening, Walgreens and Bausch + Lomb recently announced a new SightSense online and in-store patient education program — an initiative to heighten eye health awareness and encourage consumers to take proactive steps to protect and preserve their sight. The program features a special eye health section on Walgreens.com that provides tools, information and resources to help consumers become informed and proactive in their eye health. The website also provides an eye care professional locator for consumers to find an eye doctor near them, as well as a list of upcoming in-store events.
Also down the street from the newest Walgreens location is the chain’s governmental affairs office, which means Walgreens will be able to showcase first hand the full cost-savings potential a pharmacy can bring to bear. "We’re … positioned to help influence health care in this country," Kermit Crawford — Walgreens’ president of pharmacy, health and wellness — told DSN on a tour of the store. Through medication therapy management and similar programs, the pharmacist can help improve medication adherence, Crawford said. The Take Care Health Clinic represents a healthcare facility that is as convenient to access as an emergency room but can deliver care at a much lower cost than the ER. The walk-in availability of immunizations, not just flu shots, also helps mitigate healthcare cost as more people get inoculated because it’s readily available and convenient.
Alcon launches mobile website
NEW YORK — Alcon has launched a mobile website designed to facilitate dialogue between patients and pharmacists about eye and ear treatments, the company said Thursday.
Alcon announced the launch of Drops101 Web Tools, which offers access to information about two of its products: Ciprodex Otic (ciprofloxacin and dexamethasone), for acute otitis externa and acute otitis media in children with tymponostomy tubes; and Moxeza ophthalmic solution (moxifloxacin hydrochloride) for bacterial conjunctivitis.
"We heard from pharmacists that having a one-stop digital resource to help advise patients on prescribed medications would be useful," Alcon U.S. multi-channel marketing manager Amy Patyk said. "Drops101 is another way Alcon is expanding our commitment to meet the ever-evolving needs of pharmacists and their patients."
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