Generics in HIV, a Pharmacoeconomic Reality: How to Manage Change in Europe?

 Generics in HIV, a Pharmacoeconomic Reality: How to Manage Change in Europe?

  PR Newswire

  PARIS, March 28, 2013

PARIS, March 28, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) announced
highlights from its Symposium, "Antiretrovirals (ARVs) & Generics, a new
Challenge for Pharmacists: how will we manage change in Europe?," which was
held during the 18th Congress of the European Association of Hospital
Pharmacists (EAHP) in Paris, France on March 14, 2013.

Today, more than 34 million people are infected with HIV and approximately
14.8 million need treatment; yet only about 8 million receive any (WHO 2012).
The symposium aimed to raise awareness on the pharmacoeconomic and therapeutic
issues related to generics of HIV treatments and enable professionals and
experts to share perspectives and experiences. Three major issues emerged:

Provision of ARVs, a pharmacoeconomic challenge "Due to the success of HAART
(Highly Active Antiretroviral Therapy), people living with HIV are now
considered to have a long-term chronic illness. However, patient numbers will
continue to increase annually creating a rising financial burden on national
healthcare systems. The availability of generic ARVs will provide significant
cost reduction opportunities in an increasingly challenging financial
environment without detriment to patient care," said Peter Sharott, Chairman
of the Symposium (London Specialised Commissioning Group).

"Generic fixed-dose-combinations are becoming the standard of care in 1st line
Antiretroviral Therapy in low and middle income countries and help to simplify
complex live-long combination treatment," added Dr. Thomas Mertenskoetter
(T.O.M. Life Science Consulting, Hamburg, Germany). "Major aspects of
treatment strategies are antiviral efficacy, safety, convenience of dosing,
and now, with the entry of generic high quality products in high income
countries, economic considerations will be further factored in."

Patient adherence to treatment is fundamental in chronic diseases "It is
crucial to give specific consideration to the needs of patients when
introducing any change to their existing ARVs regimens to ensure that they
continue to take their medicines correctly," noted Peter Sharott.

Neal Marshall (Royal Free London NHS Foundation Trust and HIV Pharmacy
Association, London, UK) agrees: "Although the availability of the same
molecule produced by a wide range of companies can drive down price, this does
have the potential to confuse patients and might lead to short term compliance
issues if no proper counseling and information is given. Engaging both
patients and doctors in cost-based therapy switches is key for their safe and
effective implementation, and pharmacists play a key role within this."

Generic vs originator: a proven bioequivalence Regarding questions on the
efficiency of generics, Dr. Albert Darque (Hopital de la Conception,
Marseille, France) noted, "Generic drugs are required to have the same active
ingredient, dosage, and route of administration as the reference product and
must scientifically demonstrate that their product is bioequivalent to the
originator by comparing their respective bioavailabilities."

Mylan and HIV/AIDS Mylan has been a leading global player in the ARV arena for
more than a decade. In 2003, Mylan Laboratories Limited (formerly Matrix
Laboratories Limited) began providing reliable supplies of ARV active
pharmaceutical ingredients to generic drug makers. In 2007, the company began
offering finished dosage forms and launched a line of pediatric ARVs. Today,
Mylan is widely respected for the quality, dependability and affordability of
its ARVs. Mylan supplies ARVs to more than 120 countries around the world and
nearly 40% of HIV/AIDS patients receiving treatment in developing countries
depend on one of the company's ARV products.

About Mylan Mylan is a global pharmaceutical company committed to setting new
standards in health care. Working together around the world to provide 7
billion people access to high quality medicine, we innovate to satisfy unmet
needs; make reliability and service excellence a habit; do what's right, not
what's easy; and impact the future through passionate global leadership. We
offer a growing portfolio of approximately 1,100 generic pharmaceuticals and
several brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in
developing countries depend. We also operate one of the largest active
pharmaceutical ingredient manufacturers and currently market products in
approximately 140 countries and territories. Our workforce of more than 20,000
people is dedicated to improving the customer experience and increasing
pharmaceutical access to consumers around the world. But don't take our word
for it. See for yourself. See inside.

Contact: Sophie BAUMONT, EDELMAN Paris, Account Manager, Tel: + 33 (0)1 56 69
75 94,, for Mylan Inc.
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