Mylan has a decades-long track record of expanding people’s access to medicine, particularly by making more affordable generic versions of brand name drugs – expertise we’re now bringing to biologics, insulins and other complex medicines.
Helped establish the generic industry’s first trade association
Helped give rise to legislation creating the modern generics industry
Helped modernize Medicare, including the introduction of a prescription-drug benefit
Helped lead the way to ensure one quality standard for all medicines sold in the U.S.
Helped identify shift in formulary designs and CMS policy causing higher out-of-pocket costs to seniors
In 1984, generic drugs made up only 19% of prescriptions dispensed in the U.S.
In 2018, they made up 90% of prescriptions dispensed1
Generic prescription medicines cost significantly less than brand name drugs. But some healthcare plans and current Medicare policies are treating generics and brands the same when it comes to determining what out of pocket rate patients will be charged for their medicine. Even worse, some health plans aren’t even offering their patients the lower cost generic once it’s available.2
Biologics now account for about 40% of all U.S. drug spending and 70% of spending growth from 2010 to 2015.4 It’s estimated that the introduction of biosimilars in the U.S. could save the nation’s healthcare system up to $150B in savings.5 We believe that if restrictive policies and other barriers to entry are addressed, the savings could be even greater.
Policymakers can help unlock the value of biosimilars in the U.S.
Improve access to biosimilars by STOPPING DELAY
biosimilars such as REMS6 abuse through denied access to samples.
Accelerate GREATER EDUCATION of HCPs8, patients
and others on safety and reliability of biosimilars.
Biologics account for nearly 40% of all prescription drug spending, at least 70%9 of drug spending growth, and most biologics lack biosimilar competition.10
Patients and healthcare providers can rely upon the safety and effectiveness of a biosimilar product for its approved indications, just as they would the already-approved brand version of the biologic, called the reference product.
Biosimilars are held to a rigorous approval process by the FDA that includes the same robust quality standards as reference biologics.11
An interchangeable biologic is not a "better" biosimilar. The interchangeability designation is not a requirement for a physician to prescribe a biosimilar.
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.11
Health authorities rigorously evaluate data comparing a biosimilar to its reference product including a detailed analytical comparison, followed by animal studies if necessary and then comparative clinical studies. Very powerful and sensitive analytical tools measure how biosimilars will perform in the body to have their desired effect.12
Biosimilar manufacturers must demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of the safety and effectiveness of the product for patients.13
Requiring patients to “fail first” on a reference biologic before accessing a biosimilar has no clinical rationale, according to FDA.14 As a condition of FDA approval, a biosimilar must demonstrate it works in the body as the biologic does.
Patients have over 700 million days of experience using biosimilars outside the U.S.15
Competition from biosimilars is crucial to improve patient access to more treatment options including some lifesaving medications as well as spur innovation for future therapies.16
of all people worldwide being treated for HIV/ AIDS depend on a Mylan antiretroviral product.
of Mylan’s active pharmaceutical ingredient manufacturing capacity is devoted to antiretrovirals.