FDA approves biosimilars - but what does this mean for YOU?

'Biosimilars are here. They are now here today. The simple ones have been approved ... and the complex ones have also been approved.'

Don't get caught off-guard when your doctor prescribes a biosimilar instead of a brand name or generic medication.

LOS ANGELES, CA (Catholic Online) - According to the U.S. Food and Drug Administration (FDA), another biosimilar product has been approved in the United States.

Biosimilar drugs are manufactured from living organisms instead of created via chemical synthesis, making medications significantly cheaper.

Though biosimilars are created differently than brand name or chemically synthesized  medications, they are no less potent.

In fact, the FDA posted a Fact Sheet slide show titled the "FDA's Overview of the Regulatory Guidance for the Development and Approval of Biosimilar products in the US."

On March 6, 2015, the FDA approved the first biosimilar product Zarxio.

Zarxio can be prescribed for:

• patients with cancer receiving myelosuppressive chemotherapy
• patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
• patients with cancer undergoing bone marrow transplantation
• patients undergoing autologous peripheral blood progenitor cell collection and therapy
• patients with severe chronic neutropenia

Another biosimilar drug, Remicade, has been approved by the FDA earlier this month.

Remicade is used to treat:

• adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
• adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
• patients with moderately to severely active rheumatoid arthritis in combination with methotrexate
• patients with active ankylosing spondylitis (arthritis of the spine)
• patients with active psoriatic arthritis
• adult patients with chronic severe plaque psoriasis

Dennis Lanfear, the CEO of biosimilar company Coherus Biosciences, told Business Insider the simple biosimilars were easily approved but the more complex biosimilar drugs are finally on the market now.

"Biosimilars are here," Lanfear explained. "They are now here today. The simple ones have been approved like Zarxio, and the complex ones have also been approved."

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