Mylan tapped as Gilead’s exclusive business partner for India
PITTSBURGH and MUMBAI, India — Mylan announced that its India-based subsidiary, Mylan Pharmaceuticals Private Limited, has been named Gilead Sciences’ branded medicines business partner for India.
Under this exclusive agreement, Mylan will market and distribute in India the following drugs from Gilead:
- HIV therapies Viread (tenofovir disoproxil fumarate), Truvada (emtricitabine/tenofovir disoproxil fumarate) and the newer single-tablet regiment Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg);
- AmBisome (amphotericin B liposome for injection), used to treat life-threatening, systemic fungal infections. It’s also used to treat the parasitic disease visceral leishmaniasis; and
- Viread for its use as a treatment for chronic hepatitis B virus (HBV) infection.
"This further extension of our collaboration with Gilead builds off of our existing successful partnership manufacturing and supplying high-quality, cost-effective generic antiretroviral therapy for those in resource challenged countries, delivering on our mission of providing access to high quality medicine to the world’s seven billion people," Mylan CEO Heather Bresch said.
Mylan was selected in September 2012 as a leading supplier of antiretroviral medication to India’s National AIDS Control Organization. India is home to the world’s largest-population of people with HIV/AIDS, with approximately 2.4 million people living with the disease.
Indiana Senate passes generic biologic pathway legislation
WASHINGTON — The Biotechnology Industry Organization and the Indiana Health Industry Forum on Thursday commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.
Although similar bills have been addressed in other states, SB 262 enjoys the support of a broad coalition of both biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record. This legislation represents a significant step forward and ensures transparency and communication between patients and their treatment teams.
While the Food and Drug Administration oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors are covered by state law. SB 262 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies.
Bills such as this that properly address the important aspect of physician communication represent model legislation necessary in all 50 states to address this cutting-edge technology, BIO said.
The FDA currently is developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process, BIO noted.
Novo Nordisk announces new SVP
PRINCETON, N.J. — Global healthcare company Novo Nordisk announced the promotion of Eddie Williams to SVP biopharmaceuticals, effective Feb. 1, 2014.
"Our biopharmaceutical business will be increasingly important to our growth in the U.S. as we apply the protein expertise developed through our diabetes franchise to helping people with hemophilia and growth disorders manage their conditions more effectively," Jesper Hoiland, president of Novo Nordisk, the company’s U.S. affiliate, said. "That business has flourished under Eddie’s experienced leadership. His promotion to senior vice president demonstrates the company’s focus on, and commitment to, our pipeline of life-changing biological therapies."
Williams joined Novo Nordisk in 2006 and currently serves as corporate VP biopharmaceuticals, a role in which he leads the sales and marketing, business development and new product commercialization functions for the company’s growing U.S. biopharmaceuticals business.