Infectious Diseases
Fighting Infectious Diseases
Thanks to modern medications, patients with infectious diseases such as HIV/AIDS, hepatitis and tuberculosis who receive the proper care can lead long and healthy lives. However, preventing and diagnosing the diseases and ensuring patients have access to life-saving medications, especially in low- and middle-income countries where the burden is most prevalent, are still global challenges. We are proud of the leadership role we have in this area and continually seek opportunities to do more.
Women’s Health
Increasing Care for Women
Mylan’s Women’s Health portfolio spans oncology, hypothyroidism, diabetes and menopause, among other health concerns predominant in women. As part of our commitment to the U.N.’s Every Woman Every Child initiative, Mylan pledged to register our contraceptives portfolio in 80% of Family Planning 2020 target countries (among the poorest countries in the world) by 2020, which we achieved.1 An additional goal is to provide contraceptives to 25 million women and girls in FP2020 countries. Our receipt in 2018 of the first World Health Organization (WHO) Prequalification for Medroxyprogesterone Acetate, 150 mg (IM DMPA), a generic injectable for Depo-Provera® that provides three months of birth control protection, should help further that effort. In 2019, we provided contraceptives to >14 million women and girls and launched new generation contraceptive products in the private market through distribution partners in the Philippines, Taiwan, Mauritius, Tanzania, Mongolia and Thailand to reduce discontinuation rate (happening due to adverse effects).
1For target countries with registrations and countries that accept products via import permits.
Biosimilars
Unlocking Greater Access to More Affordable Care
Biologics represent the cutting edge of medical science and have become the standard of care for many devastating and debilitating diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. Due to their complexity, biologics can be expensive and, in some cases, out of reach for patients.
Biosimilars are biologic medicines. According to regulatory authorities, there are no clinically meaningful differences between a biosimilar and its reference product in terms of safety and efficacy. While variations in all biologics are normal and expected, they must remain within a permitted range for the drug to be approved.
Following years of innovation and R&D, Mylan offers a diverse biosimilars portfolio that includes 20 biosimilars and insulin analogs on the market or in development. Further, Mylan has regulatory approvals for biosimilars in more than 85 countries. That’s a result of our deep experience and ability to develop and manufacture complex products as well as our strong partnerships with companies including Biocon, Momenta, Fujifilm Kyowa Kirin Biologics and Revance.
Expanding Serialization
Serialization is fueled by myriad government regulations that require Mylan to track our products along the supply chain and verify their authenticity.
We comply with the U.S. Drug Supply Chain Security Act and the European Union Falsified Medicine Directive. We employ serialization technology such as a 2D matrix on all products. Work also includes the gathering of data from the matrices so that we can identify and manage procedures associated with individual units regarding product picking, packing, shipping, sampling, returns and destructions.
Fighting Falsified Medicine
We’ve made significant investments in packaging and information technology to enhance product safety. By lowering the likelihood that falsified products will enter our supply chain, we are helping ensure access to high quality medicine. Global policies have been established to govern validation, operations and product security. New and updated procedures have also been implemented across all manufacturing sites to drive consistency in packaging, management and distribution of serialized product. Among these are processes to track and trace serialized products. An internal product safety group helps monitor the supply chain to help ensure it is not breached.
Pharmacovigilance Program
Our Pharmacovigilance (PV) program, coupled with a global policy on product safety, guides Mylan’s approach to ensuring patient care and safety in relation to the use of our marketed products. In line with applicable global legislation, we have a cross-functional team of medical and scientific professionals that support a global pharmacovigilance system that reports our risk/benefit assessments to global health authorities.
Our Product Safety and Risk Management (PSRM) department is a key component of our program and is responsible for conducting internal and external audits along with ensuring that the personal health information of those participating in our clinical trials is carefully safeguarded. It is subject to external audits and inspections from health authorities around the globe.
Mylan’s Corporate Product Safety Committee provides a forum for the periodic and ad hoc evaluation of newly emerging safety information regarding our products. Potential safety signals are assessed and evaluated through our corporate safety governance structure and new information is communicated in a timely manner to healthcare professionals, patients and health authorities. Mylan currently has more than 300 risk management plans and associated interventional measures designed to ensure all of Mylan’s products are used safely and effectively.
We conduct training that complements Mylan’s policy on Pharmacovigilance Training Standards which defines training curriculum, frequency, effectiveness measurements and documentation and other requirements. PSRM employees are assigned professional development training courses based on individual experience. In 2019, in addition to the 16 PV audits conducted by Mylan’s global Quality team, there were four external audits by business partners and four PV inspections by national health authorities conducted at Mylan’s facilities. Mylan submitted about 250,000 individual case safety reports and more than 1,600 aggregate.