Coherus Biosciences Inc (NASDAQ:CHRS) submitted a biologics licensing application (BLA) for its lead biosimilar development candidate earlier this month, and is drawing a lot of speculative attention based on the potential impact of the drug it’s trying to get approved. Here is why.
The drug in question is called CHS-1701 and it’s an oncology candidate. Before we get into that in too much detail, however, let’s quickly address the biologics and the biosimilar spaces. Biologics are a type of treatment derived from living organisms, rather than chemically synthesized. They are all more complicated than chemical drugs, and much larger in size. This makes them more difficult to copy, and in turn, makes it more difficult for a company to create a generic version of a biologic.
Rather than create an exact copy (because it is not possible) the FDA has set up a framework for approving what it calls biosimilars. Essentially, a generic drug company makes its own biologic and attempts to make it as similar as possible to the drug it is trying to imitate. It then goes about proving the similarity by way of clinical trials. If the data from these trials demonstrates non-inferiority from an efficacy perspective, and the safety profiles are similar, the FDA will approve the drug. Think of it as a generic drug, but for a biologic rather than a chemical drug.
So, with CHS-1701, Coherus Biosciences Inc (NASDAQ:CHRS) is trying to make a biosimilar (generic) version of a drug called pegfilgrastim, which was developed by Amgen, Inc. (NASDAQ:AMGN), approved in 2002 and now markets as Neulasta in the US. It is the largest selling oncology product in the US, meaning Coherus would have a huge market opportunity if it can demonstrate non-inferiority and get an FDA green light for commercialization.
It’s not all that straightforward, however.
By way of its Sandoz subsidiary, Novartis AG (ADR) (NYSE:NVS) tried to get its own biosimilar version of Neulasta approved in the US, however the agency turned the drug down in July. We don’t have the exact details, Sandoz was pretty vague on what the complete response letter cited as the reason behind the decline, but we know that the data on which the Sandoz BLA rested looked pretty solid. Sandoz already pick up approval for one of Amgen, Inc. (NASDAQ:AMGN)’s drugs, Neupogen, and looks set to pick up another for its Enbrel biosimilar any day now (an advisory just unanimously voted in favor of its approval), so the FDA isn’t averse to giving these types of drugs the thumbs up – meaning it must’ve been something specific related to the application.
So what about the data for this one? Well, the company reported topline back in July, and the drug met all of its coprimary endpoints across a range of comparison targets, and just as importantly, the confidence intervals that addressed the equivalency when bang in the middle of the prespecified range of 80% to 125%. To put this in a little simpler terms, the drug went up against its pegfilgrastim target and performed just as well in pretty much every important aspect of comparison.
So what’s the take away here? Well, Sandoz didn’t have much luck with its biosimilar, but there looks to be no reason (based on information we have) that Coherus Biosciences Inc (NASDAQ:CHRS) will be in the same position come decision day. The FDA is on a sweep of BLA approvals, and advisory panels seem to love these new generation treatments. Efficacy is there, safety is there, and equivalency is there, and the market exceeds $4 billion at saturation. There’s going to be competition, of course. Especially if Sandoz reapplies for for approval (which it will almost certainly did) and brings its own biosimilar to market to compete not just with the branded version but also CHS-1701. Having said this, if Coherus can get first-to-market it will have a distinct advantage from a marketing perspective, and if it can execute on a solid commercialization strategy, it should be able to quickly attract some of these $4 billion revenues away from Amgen, Inc. (NASDAQ:AMGN)’s sheet and towards its own.
We’re looking to acceptance of the BLA as the next catalyst, and beyond that, an advisory review followed by decision day.
Note: This article is written by Mark Collins and originally published at Market Exclusive.