Mylan public health patient advocacy
One of the most powerful ways to serve patients in need is by speaking out on their behalf.

Mylan works with government, trade associations, healthcare providers, patient advocacy groups and others to shape policies that help people across the nation enjoy better health.

Read a summary of Mylan’s 2018 Global Social Responsibility Report

MAKING MEDICINE MORE ACCESSIBLE

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.

  1. Helped establish the generic industry’s first trade association

    1982
  2. Helped give rise to legislation creating the modern generics industry

    1984
  3. Helped modernize Medicare, including the introduction of a prescription-drug benefit

    2003
  4. Helped lead the way to ensure one quality standard for all medicines sold in the U.S.

    2012
  5. Helped identify shift in formulary designs and CMS policy causing higher out-of-pocket costs to seniors

    2018
Mylan 19 piechart

In 1984, generic drugs made up only 19% of prescriptions dispensed in the U.S.

Mylan 90 piechart

In 2018, they made up 90% of prescriptions dispensed1

Harnessing the value of generic medicines

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

Since 2015, seniors in Part D have paid $22 billion in extra, unnecessary costs as a result of these trends.2

Together, we can change these policies to harness the value of generics for patients and taxpayers:

  1. 1. Patients should have access to generics

    Patients should have access to lower cost FDA-approved generics immediately after launch. Adding generics to health plan formularies keeps costs low for everyone and makes sure patients get the benefit of lower cost medicine.

  2. 2. Patients should get the benefit of generics

    When health plans mix lower cost generics onto brand drug tiers, patients get stuck paying the higher out-of-pocket brand rate for each prescription.2 The whole system, from the federal government to your insurance company to the pharmacist, has a responsibility to make sure generics are treated as generics and brands as brands on tiers that determine what out-of-pocket rate.

  3. 3. Patients should also get the benefit of specialty generics

    Specialty medicines represent some of the most costly and most frequently prescribed drugs in the U.S.3 Patients should also get the benefit of lower cost specialty generics and biosimilars with lower out-of-pocket costs relative to brands.4

Expanding Access to Biosimilars

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.

  1. Encourage GREATER USE OF BIOSIMILARS,
    especially in Medicare.

    1
  2. Improve access to biosimilars by STOPPING DELAY TACTICS to
    biosimilars such as REMS6 abuse through denied access to samples.

    2
  3. Ensure BALANCED TRADE AND IP7 POLICY
    to expand access to biosimilars.

    3
  4. Enhance biosimilars through APPROPRIATE
    REGULATORY POLICY.

    4
  5. Accelerate GREATER EDUCATION of HCPs8, patients
    and others on safety and reliability of biosimilars.

    5

Biosimilars: 10 Things You Need to Know

Cost Barriers Today

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

Safe and Effective

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.

Same Robust Quality Standards

Biosimilars are held to a rigorous approval process by the FDA that includes the same robust quality standards as reference biologics.11

Interchangeability not required to prescribe biosimilars

An interchangeable biologic is not a "better" biosimilar. The interchangeability designation is not a requirement for a physician to prescribe a biosimilar.

Biologics are Inherently Variable

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

Strong Analytics

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

No Clinically Meaningful Differences

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

“Fail first” on Biologic Policies Lack Clinical Rationale

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.

Vast Clinical Experience

Patients have over 700 million days of experience using biosimilars outside the U.S.15

Competition is Needed

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

Addressing an important need in schools

Epinephrine is the only first-line treatment for anaphylaxis, a potentially life-threatening allergic reaction.
  • Several years ago, we recognized that epinephrine auto-injectors needed to be as accessible as defibrillators are in public spaces.
  • Since then, Mylan advocated for legislation to permit “undesignated” epinephrine auto-injectors in schools – meaning a prescription could be in a school’s name rather than in a child’s name and any individual experiencing an anaphylactic reaction would have access to the epinephrine autoinjectors.
Today, 48 states have adopted such laws, and Mylan has donated more than 1 million epinephrine auto-injectors to more than 73,000 schools around the country.

Stemming the Tide of HIV/AIDS

Helping those in need is a gift that benefits everyone. Mylan is the world’s largest producer of HIV/AIDS drugs.

~40%

of all people worldwide being treated for HIV/ AIDS depend on a Mylan antiretroviral product.

>50%

of Mylan’s active pharmaceutical ingredient manufacturing capacity is devoted to antiretrovirals.

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