The medical marketplace is about to get bigger. The Food and Drug Administration (FDA) has approved a second biosimilar product, Inflectra, to Remicade (infliximab) and expects to approve other biosimilars , too. The FDA approved Zarxio, a biosimilar to Neupogen (filgrastim), in March 2015.

This comes at a time when India is witnessing much litigation over biosimilars. Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms such as yeast and bacteria.

FDA’s Leah Christl explains: “Biologics are different from conventional medications. Conventional medications — drugs — are generally made from chemicals, or chemically synthesised, and therefore their structure can be relatively easily defined.”

Biologics, however, can’t be made by following a chemical “recipe.” “Biologics come from living organisms that are variable in nature. In addition, they are generally more complex and not as easy to define and characterise,” she adds. Because of that, developing biologics is a far more complex process than manufacturing drugs.

The FDA rigorously evaluates a biologic’s safety and effectiveness before granting it approval. Currently, biologics are among the fastest growing segments of the prescription product market.

“It is important to note that a biosimilar is not just like a generic drug,” says Christl. Because of the differences in the complexity of the structure and the process used to make a biologic, biosimilars are not as easy to produce as generics (copies of brand name drugs). A biosimilar is not an exact duplicate of another biologic; rather it is highly similar to the reference product.

Biosimilars are likely to creating greater competition in the medical marketplace, Christl says. And this could not only increase treatment options for patients but also lead to less expensive alternatives to comparable products.

Source: USFDA

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