An Understanding of Biologics & Biosimilars

Emily Alexander – Director, Regional Lead, U.S. Regulatory Affairs, AbbVieHayden Rhudy – Director, Therapeutic Area Strategies, AbbVie

http://www.spinalcord.org/webinar-archive/

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Overview of Biologics

Introduction to Biosimilars

Open Policy Questions Related to Biosimilars

Q&A

Agenda

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Biologics Are Far More Complex Than Conventional Medicines

Aspirin

Monoclonal AntibodyConventional drugs (small-molecule,

chemically synthesized medicines)

180 Daltons andZero Amino Acids

148,000 Daltons and1,330 Amino Acids

Biologics (large molecule medicines)

Small, simple moleculesOften tablets or creams

Large, complex moleculesOften injected or infused

Made through simple chemical reactions

Grown in living organisms

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• Vaccines

• Human growth hormones

• Interferons

• Thrombolytics (Clot Busters )

• Insulins

• Botulinum toxins

• Monoclonal antibodies

• And many more!– Biologics treat a wide array of conditions, including cancer, multiple sclerosis,

rheumatoid arthritis, ulcerative colitis, diabetes, spasticity, psoriasis, cystic fibrosis, respiratory virus

– Hundreds of biologics are in development to treat areas of unmet medical needs, including Alzheimer’s disease

Examples of Biologics

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How are biologics different from small

molecules?

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Generic Copy of Small-Molecule Medicine: SAMENESS

Small molecule medicines have

simple structures and are made through relatively simple manufacturing

processes (that aren’t sensitive to changes)

Identical copy can be made by unrelated

manufacturers (i.e., a generic copy);

approved on basis of sameness

Generic will have identical clinical

effect in any indication (or disease)

Automatic substitution at

pharmacy results

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Biosimilar Copy of Biologic: SIMILARITY

Biologics have large, complex structures

and are made through complex

manufacturing processes (that are

very sensitive to small changes)

Only a “similar’ version can be

created; impossible for an identical copy

to be made

May have small differences in clinical effect; approval of all

indications is not automatic

Automatic substitution is not

typically allowed for biologics; requires a higher standard of

evidence in the United States

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• Generics have been on the market in the U.S. for many decades; most policy decisions are relatively settled

• Policymakers recognized the need for a separate pathway for biosimilars from generics because of the different policy questions posed by a product that is similar but not the same

• FDA did not have authority to approve biosimilars until March 2010, when Congress enacted the Biologics Price Competition and Innovation Act

• To date, no biosimilars have been approved (but several applications are pending)

• This new type of product and new approval standard (similarity) raises many new policy questions that will impact patients, regulators, physicians, pharmacists, and many others!

U.S. Biosimilar Regulation

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Substitution/Notification: State legislation has been proposed to regulate the substitution of biosimilars with the reference product.

Naming: The FDA will decide whether biosimilars will have the same name as their reference product.

Interchangeability: This year, the FDA will be deciding what standards must be met for a biosimilar medicine to be determined “interchangeable” with the original biologic medicine.

Rigorous Testing for Each Condition: The FDA will be determining whether drug companies must conduct rigorous clinical testing to prove that a biosimilar works in each and every condition

Important Policy Issues for Individuals living with Spinal Cord Injuries/Disorders

Call to ActionRequest to Congress:

•Please hold oversight hearings on this important process and urge the FDA to release clear guidance as soon as possible that ensure patient safety, patient access to the right biologic medicines, patient choice and full transparency.

•Choice should be at the center of any decision to substitute or switch therapies and should only be decided by the consumer and provider. Consumer choice needs to be preserved and regulatory decisions must be based on sound science.

•Biosimilar regulations must put consumer safety first. Policymakers and regulators must address appropriate consumer safety and efficacy concerns as they relate to decisions around interchangeability, clinical indications, labeling, naming and substitution.

•Particular attention must be given to assure that rigorous clinical testing proves that a biosimilar works safely in each and every condition or disease for which it is approved to be prescribed, as well as in each distinct group of individuals with that disease.

•Ensure pharmacists maintain records of substitutions for significant periods of time would allow the medical community to track long-term treatment outcomes of biosimilars.

Roll on Capitol Hill, 2015

June 7-10, 2015

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Over 100 advocates participate from across the country for over 200 scheduled meetings with Members of Congress and Congressional

staffers to advocate on healthcare, transportation, and disability rights issues that impact access, mobility and independence of all those

impacted by spinal cord injuries and disorders.

• Sunday June 7: Arrival and Welcome Reception• Monday June 8: Education Sessions, Speaker Panels and Presentations, Advocacy Training• Tuesday June 9: Capitol Hill Meetings followed by Congressional Awards Reception• Wednesday June 10: Advocate Recognition Breakfast

http://www.unitedspinal.org/events/roll-on-capitol-hill

THANK YOUQUESTIONS?

To ask a question or make a comment, please type it in the

“Questions” box on the right of your screenabennewith@unitedspinal.org