Generics dominated headlines in 1984 when Congress approved the landmark Hatch-Waxman Amendments. At the time, the idea of biologics was far away. Three decades later, the first batch of biosmilars is nearing approval in the U.S. And like generics before them, they are opening up new avenues of growth and generating new challenges at the same time.
Biosimilars vs Generics
Generics are drugs comparable to existing small molecule drugs. In other words, they are drugs which can be recreated under laboratory conditions following standardized procedures. Biosimilars are approved versions of biologics, which are far more complex drugs.
Biosimilars are proteins generated by living cells and are much larger molecules. The most common example used to illustrate the difference between a biologic and its biosimilar is a family recipe passed onto a new chef. In other words, the effects of a biosimilar may not be absolutely identical to those of the original biologic.
Regulatory and Clinical Hurdles
Since 2006, biosimilars have been available in the European Union. The U.S. defined the regulatory roadmap for biosimilars only in 2010. According to a draft guidance document released in 2012, the FDA said approval for biosimilars will be on the basis of “data derived from analytical studies, animal studies and a clinical study or studies.”
This is much tougher than the requirements for approving a generic. On the user side, a large amount of clinical data must be made available to physicians to convince them to prescribe such drugs. Pharma companies must also invest significant amounts in communicating their efficacy, which add on to costs.
Bright Prospects
According to a report from Frost & Sullivan, the global biosimilars space generated $1.2 billion in 2013. This is expected to touch $24 billion in 2019. Another study forecasts that the global biosimilars market will expand at a CAGR of 27.58% over 2013-2018.
The major reason for this high level of growth is the large number of patents that are expiring. Another reason is that costs incurred in the discovery of such treatments are falling. This is because manufacturing is increasingly being outsourced to emerging markets.
Below we present three pharma companies present in the biosimilar arena or quickly increasing their presence in this space, each of which also has a good Zacks Rank.
Dr. Reddy's Laboratories Ltd.
Dr. Reddy's Laboratories Ltd. (RDY) operates in the generics, active ingredients and pharmaceutical services segments. It is present in the biologics space and is expected to be a key player in biosimilars. The company has already released four large molecule products.
Dr. Reddy's Laboratories Ltd. holds a Zacks Rank #2 (Buy) and has expected earnings growth of 12.60%. The forward price-to-earnings ratios (P/E) for the current financial year (F1) is 22.26.
Actavis plc
Actavis plc (ACT) manufactures, develops and distributes pharma products in the U.S. as well as in global markets. Its biosimilars pipeline has also made good progress. Actavis has collaborated with Amgen Inc. (AMGN) to develop biosimilar versions of Herceptin, Avastin and rFSH. All three medications are in phase III trials
Currently the company holds a Zacks Rank #2 (Buy) and has expected earnings growth of 16.90%. It has a P/E (F1) of 17.04.
Biogen Idec Inc.
Our third choice is Biogen Idec Inc. (BIIB). The company is involved in drug discovery, manufacturing and marketing in the U.S. as well as abroad. In 2012, the company and Samsung Biologics announced they were setting up a biosimilars joint venture (JV). In December 2013, Biogen announced that it would commercialize certain biosimilar products in Europe as per the terms of this JV.
Besides a Zacks Rank #1 (Strong Buy), Biogen Idec has expected earnings growth of 28.50%. It has a P/E (F1) of 29.38.
Despite regulatory hurdles and user level challenges, biosimilars are quickly emerging as products of the future. This is why each of these stocks would make good additions to your portfolio.
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