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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. This is to be expected in a space where neither the regulators nor the sector have a large amount of experience. The main requirement is a specific trial to determine whether the biosimilar is as safe and effective as the original when patients are switched. The trial design does not appear to be demanding, with one arm remaining on the original drug and one switching multiple times between the two a less complicated protocol than the four arms expected by Bernstein analyst Ronny Gal. However, the switching trial alone might not be sufficient for complex biosimilars that have not shown a high level of analytical similarity. In these cases the FDA will want additional post-marketing safety and efficacy data. While the agency has been flexible about extrapolating data in approving biosimilars for drugs with multiple indications, it might be more demanding when those same biosimilars seek an interchangeability designation.
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Are they close to a new coach? Chiefs special teams coordinator Dave Toub interviewed to become the head coach of what are now known as the Los Angeles Chargers last week. Toub also interviewed with the Denver Broncos, who hired Miami Dolphins defensive coordinator Vance Joseph on Wednesday. For now, Toub directs his attention to the Chiefs, who are preparing to face the Pittsburgh Steelers in Sundays AFC Divisional playoff game. The interviews went well, Toub said. Moved on now, were getting ready for Pittsburgh. Toubs two interviews bring to four the number of times hes been a finalist for an NFL head coaching job. In past years, hes interviewed with the Chicago Bears, where he spent nine seasons as an assistant coach, and with the Dolphins. Denver Broncos hire Vance Joseph as new head coach Each time I do one I feel like Ive gotten better, Toub said. I think its good because the awareness that a special teams coach can actually do the job has really come to the forefront this year. I think down the road its only a matter of time before it gets done. The Chargers formally announced their move from San Diego to Los Angeles on Thursday and Toub said the topic was part of the interview. Other reported finalists for the job are Lions defensive coordinator Teryl Austin, Bills offensive coordinator Anthony Lynn, Patriots defensive coordinator Matt Patricia and Bucs defensive coordinator Mike Smith.
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