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FDA Unprecedentedly Approves Use of Biosimilar in the US

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FDA Unprecedentedly Approves Use of Biosimilar in the US
On March 6, 2015, the FDA (Food and Drug Administration) announced that it had approved the very first “biosimilar” product in the US. Zarxio (filgrastim-sndz) will now be available for purchase (1).

Thanks to the Affordable Care Act that included the Biologics Price Competition and Innovation Act of 2009, such products can now be approved by the FDA.

The 2009 Act is paving the way for an “abbreviated licensure pathway for biological products shown to be ‘biosimilar’ to or ‘interchangeable’ with an FDA-licensed biological product, called the “reference product.” (2)




What Is a Biosimilar Product?

The FDA defines biosimilar products as “generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.”

Simply put, a biosimilar product is “a biologic medical product which is a copy of an original product that is manufactured by a different company.” (3)

There are two main criteria that a biosimilar must demonstrate:

–> Must be “highly similar” to an FDA approved biological product (reference product).
–> Must have no clinically meaningful differences in safety and effectiveness of the reference product.

Only minor differences in clinically inactive components are allowed and must meet “additional standards for interchangeability.” (4)

David Kroll of Forbes defines biologics as, “drugs that are generally made in living organisms to which recombinant DNA is added. The complexity of the living organism also determines how difficult the ‘biomanufacturing’ process can be, whether it’s in bacteria, yeast, plants, or mammalian cell.” (5)

“Recombinant DNA (rDNA) molecules are DNA molecules” that are created by laboratory methods that use genetic recombination (such as molecular cloning). The method creates genetic material that has multiple sources. The end result of genetic sequences are ones that aren’t normally found in biological organisms (6).

biosimilars patent

Biosimiars Aren’t Generic Drugs

Biosimilars aren’t to be confused with generic drugs. Generic drugs are simply copies of brand name drugs and contain the exact same active ingredients found in the original drug. Generic drugs are known as bioequivalents since they have the same performance, dosage, safety, etc. as the original drug.

Unlike generic drugs, a biosimilar has “highly similar” equivalents to the reference product (original), but features allowable differences. That’s because the biosimilar is made from living organisms. Even though there are differences between the biosimilar and the reference product, there aren’t any “meaningful” clinical differences when it comes to such as purity, potency and safety.

The FDA defines biological products as being like other medications “used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer.” (7)

Conventional drugs and biological products are distinctively different. First, biological products have a highly complex structure. The molecules are larger. They also are comprised of a mixture of molecules that are often difficult to characterize or identify. Conventional drugs are composed of “pure chemical substances”. Their structures are easily identifiable.

The biosimilar approved, Zarxio is manufactured by Sandoz, Inc.(Princeton, New Jersey) and is biosimilar to Neupogen (filgrastim), that is marketed by Amgen Inc. (Thousand Oaks, California).

Neupogen was licensed in 1991 and is administered to patients with:

–> Cancer receiving myelosuppressive chemotherapy
–> Acute myeloid leukemia receiving induction or consolidation chemotherapy
–> Cancer undergoing bone marrow transplantation
–> Severe chronic neutropenia
–> Undergoing autologous peripheral blood progenitor cell collection and therapy

In the March press release, FDA Commissioner Margaret A. Hamburg, M.D. stated, “Biosimilars will provide access to important therapies for patients who need them…” (1)

recombinant dna

Side Effects of Biosimilar Zarxio

Like most drugs, Zarxio has possible side effects.

Minor side effects include:

–> Aching in the bones or muscles
–> Redness, swelling or itching at injection site

Serious side effects include:

–> Spleen rupture
–> Serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes
–> Fast pulse and sweating
–> Acute respiratory distress syndrome
–> Lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

Side effects for Neupogen are similar and may include additional issues (8).

While biosimilars are touted as being cheaper than their reference counterparts, Forbes Kroll warns not to hold your breath if the European pricing for Neupogen is any comparison point.

References & Image Credits:
(1) FDA
(2) TSW: Will the Health Care Reform Bill Even Make a Difference?
(3) Wikipedia: Biosimilar
(4) FDA
(5) Forbes
(6) Wikipedia: Recombinant DNA
(7) FDA
(8) Drugs.com
(9) Biosimilars Patent
(10) Recombinant DNA

Originally published on TopSecretWriters.com

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