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Sunday, June 18, 2017 6:08:28 PM
CHRS (T/$40) Coherus BioSciences, Inc. shares dropped sharply to close the week down 28% to $14.85 following its announcement that the FDA issued a CRL (Complete Response Letter) for its Biologics License Application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate. No further trials were requested by the FDA and the company expects to respond to the agency in the coming months.
The market for biosimilars -- drugs designed to be interchangeable with branded biologically based medicines -- is expected to become one of the fastest-growing segments of the pharmaceutical industry over the next decade. After all, there is $100 billion worth of biologically based drugs on the market that have either lost exclusivity or will lose patent protection by 2020, according to a report by Markets and Markets. Unfortunately, there aren't a lot of great ways for American investors to gain direct access to this emerging market. The late-stage biologics company Coherus Biosciences, however, is one glaring exception.
Coherus is presently working on resolving the outstanding issues regarding its regulatory filing for a biosimilar to Amgen's megablockbuster bone marrow drug Neulasta. The good news is that U.S. Food and Drug Administration reportedly isn't going to require the company run any additional trials in order to refile its application. So, depending on the nature of all the outstanding issues, Coherus could have an FDA-approved biosimilar for a top-selling drug on the market within the next twelve months. Although it's hard to say how much of the Neulasta market Coherus can actually capture with its copycat medicine, the drugmaker's shares should get a nice boost even if it only goes on to grab a couple hundred million dollars in annual sales at peak. Coherus, after all, presently sports a market cap of a mere $794 million following its latest dip in the wake of that regulatory setback. In all, Coherus is well-positioned to take advantage of the rapidly evolving biosimilar market, making it an outstanding growth play for savvy investors.
Coherus is researching copycat versions of a handful of multi-billion dollar drugs, including Amgen's Neulasta and Enbrel as well as AbbVie's Humira. If Coherus succeeds at bringing one of these drugs to market and can steal even a small amount of market share then it could be a financial bonanza for the business. https://www.fool.com/investing/2017/06/16/3-stocks-that-could-double-your-money.aspx?yptr=yahoo
The market for biosimilars -- drugs designed to be interchangeable with branded biologically based medicines -- is expected to become one of the fastest-growing segments of the pharmaceutical industry over the next decade. After all, there is $100 billion worth of biologically based drugs on the market that have either lost exclusivity or will lose patent protection by 2020, according to a report by Markets and Markets. Unfortunately, there aren't a lot of great ways for American investors to gain direct access to this emerging market. The late-stage biologics company Coherus Biosciences, however, is one glaring exception.
Coherus is presently working on resolving the outstanding issues regarding its regulatory filing for a biosimilar to Amgen's megablockbuster bone marrow drug Neulasta. The good news is that U.S. Food and Drug Administration reportedly isn't going to require the company run any additional trials in order to refile its application. So, depending on the nature of all the outstanding issues, Coherus could have an FDA-approved biosimilar for a top-selling drug on the market within the next twelve months. Although it's hard to say how much of the Neulasta market Coherus can actually capture with its copycat medicine, the drugmaker's shares should get a nice boost even if it only goes on to grab a couple hundred million dollars in annual sales at peak. Coherus, after all, presently sports a market cap of a mere $794 million following its latest dip in the wake of that regulatory setback. In all, Coherus is well-positioned to take advantage of the rapidly evolving biosimilar market, making it an outstanding growth play for savvy investors.
Coherus is researching copycat versions of a handful of multi-billion dollar drugs, including Amgen's Neulasta and Enbrel as well as AbbVie's Humira. If Coherus succeeds at bringing one of these drugs to market and can steal even a small amount of market share then it could be a financial bonanza for the business. https://www.fool.com/investing/2017/06/16/3-stocks-that-could-double-your-money.aspx?yptr=yahoo
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