Pa. gov signs biologics interchangeability bill
HARRISBURG, Pa. — Pennsylvania Gov. Tom Wolf last week signed a bill that will increase patient access to interchangeable biologic medicines. Wolf’s signing of Senate Bill 514 has earned him praise from both the Biotechnology Innovation Organization (BIO) and Pennsylvania Bio.
“This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain a consistent and complete medical record,” Bio president and CEO Jim Greenwood said "By signing this bill into law, Governor Wolf has added Pennsylvania to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."
Although the Food and Drug Administration is in charge of vetting and approving biologic medicines and interchangeability designation, it’s up to the states to say whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors if they do so. BIO supports full communication in the substitution process to ensure patients and prescribers know what product the patient will receive.
“We’re pleased to see Pennsylvania adopting policies that not only support a growing industry in our state, but more important, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” Pennsylvania Bio president and CEO Christopher Molineaux said. “This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments.”
Impax names new generics division president
HAYWARD, Calif. — Impax Laboratories on Monday announced the appointment of Douglas S. Boothe to the position of president of its generics division. Boothe will report directly to the specialty pharmaceutical company’s CEO and oversee its entire generics business.
“Doug is an accomplished executive with extensive generic pharmaceutical leadership and business development experience that will be instrumental in growing our generics business,” Impax president and CEO Fred Wilkinson said. “We are delighted that Doug is joining the company at an important time, as we expand our generics portfolio through the pending acquisition of products from Teva Pharmaceutical Industries and affiliates of Allergan, and prepare the strategies to maximize the return from our near term potential ANDA (abbreviated new drug application) approvals.”
Boothe had previously served as Perrigo’s EVP and general manager, where he was responsible for U.S. pharmaceuticals, including generics and specialty. From August 2008 to December 2012, he was CEO of Actavis after serving as EVP and COO for two years. Recently, he was a director of the Generic Pharmaceutical Associaton.
Mylan launches its Crestor generic
PITTSBURGH — Mylan last week launched its generic version of AstraZeneca’s Crestor (rosuvastatin calcium) tablets. The drug is indicated to treat high triglycerides in adults.
Mylan’s generic will be available in 5-, 10-, 20- and 40-mg dosage strengths. For the 12 months ended May 31, the product had U.S. sales of $6.7 billion.
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