What it will not do is unleash a flood of such products into the worlds biggest drug market. The data needed to support any claim of interchangeability are substantial, including proof that patients can be safely switched from the original product to its copycat rival, and evidence of effectiveness in all indications. The latter requirement could prove a problem for the approved agents Amjevita and Inflectra, which have only conducted switching trials in single indications. To interchange or not For the use of some products, such as those infused in hospitals, the interchangeability of biosimilars could have little influence. This is because the decisions are likely to be governed by payers or institutions pharmacy and therapeutics committees, which will determine whether to use the less expensive biosimilars based on a balance of price, safety and efficacy. Such products would include the biosimilar of Roches ( OTCQX:RHHBY ) Herceptin that Mylan (NASDAQ: MYL ) and Biocon ( OTC:BCNQY ) have submitted to the FDA, Remicade competitor Inflectra, from Pfizer (NYSE: PFE ) and Celltrion, and the Neupogen competitor Zarxio. The last two of these have been launched. But for self-administered products like Amgens (NASDAQ: AMGN ) Humira competitor Amjevita, achieving interchangeability would be a bigger coup, since the biosimilar could be substituted by a dispensing pharmacist without physician intervention in many parts of the US. Thus release of the guidelines this week is an important step for Amjevita, as well as Novartis (NYSE: NVS ) Enbrel biosimilar Erelzi, in that the FDA has finally opened the door to approving products as interchangeable. Switch to pull even The standards are high, however.
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