The biosimilar space remains in the spotlight as a number of regulatory decisions are pending. While generic drugs are follow-on versions of chemically synthesized molecules, biosimilars contain a version of the active substance of an already approved original biological drug.
Development of biosimilars is technically challenging than the development of generic drugs as the former requires clinical studies in patients and are engineered to match the reference drug in quality, safety and efficacy. Due to the complex nature of the product, the development and the regulatory pathway of biosimilars differ significantly from that of generics.
A biosimilar is usually less expensive than the branded drug. Thus the market for the same remains highly lucrative. With the acceleration in approvals of biosimilars, the market has thus attracted a lot of players which is witnessing rapid growth. Here are a few latest developments from this space:
Leading the biosimilar space is Novartis AG’s NVS generic arm Sandoz, which is a strong player in the biosimilar market with five marketed biosimilars (Omnitrope, a human growth hormone; Binocrit, an erythropoiesis-stimulating agent used to treat anemia; and filgrastim for neutropenia under the brand names Zarzio outside the United States and Zarxio in the United States.).
The company plans to launch five major oncology and immunology biosimilars between 2017 and 2020. This includes a biosimilar version of Rituxan (rituximab), which was approved by the European Commission in June 2017 (marketed as Rixathon).
Recently, the FDA accepted its Biologics License Application (BLA) for a proposed biosimilar version of Rituxan. In August 2016, Sandoz’s Erelzi, a biosimilar version of Amgen, Inc.’s AMGN blockbuster drug Enbrel gained approval in the United States for five indications. Erelzi was also approved by the European Commission in 2017.
In May 2017, the European Medicines Agency also accepted the company’s Marketing Authorization Applications for biosimilar versions of Humira (adalimumab) and Remicade (infliximab) for review. Novartis currently carries a Zacks Rank #3 (Hold).
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Generic leader Mylan NV MYL is also exploring the world of biosimilars, a market that has the potential to grow to $20 billion in 2020. The FDA recently notified Mylan and partner Biocon that the target action date for a biosimilar version of Herceptin (trastuzumab) has been extended to Dec 3, 2017.
A decision from the FDA was expected by Sep 3 but the FDA extended the review period due to review of some of the clarificatory information submitted to the agency as part of the application review process. We note that the Biocon partnership includes six biosimilar programs such as biosimilar versions of Herceptin, Neulasta, Humira, Avastin, Enbrel and Neupogen and three insulin analogs (Lantus, Humalog and NovoLog).
Mylan has a collaboration agreement with Momenta Pharmaceuticals, Inc. MNTA to develop, manufacture and commercialize up to six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate, Orencia (abatacept). Mylan currently carries a Zacks Rank #5 (Strong Sell).
Meanwhile, Amgen and Allergan plc. AGN have also submitted a BLA to the FDA for ABP 980, a biosimilar candidate to Herceptin in Jul 2017. We note that both the companies are collaborating on four oncology biosimilars, including ABP 980 which is the second to be submitted for FDA approval.
Both companies have also submitted a Marketing Authorization Application to the European Medicines Agency for the candidate earlier in 2017. We note that Amgen has a total of 10 biosimilars in its pipeline, one of which has been approved by the FDA.
In March 2017, the European Commission granted marketing authorization to Amgevita, a biosimilar version of Humira in all available indications. The companies have an important event lined up as the FDA is expected to give a decision on the approval of ABP 215, a biosimilar version of Avastin shortly. Amgen currently carries a Zacks Rank #3 (Hold).
Last month, biotech major Biogen, Inc. BIIB announced that the European Commission granted a marketing authorization for Imraldi, a biosimilar version of Humira. This is the third anti-TNF biosimilar from Biogen to receive a marketing authorization in the European Union following the approval of Benepali, a biosimilar of Enbrel and Flixabi (infliximab), a biosimilar version of Remicade. Biogen currently carries a Zacks Rank #3 (Hold).
In July 2017, Merck & Co., Inc. MRK launched Reneflexis, a biosimilar version of Remicade in the United States which was approved by the FDA in April. The FDA also granted tentative approval for Lusduna Nexvue, the biosimilar version of Lantus, basal insulin in a pre-filled dosing device. Merck currently carries a Zacks Rank #3 (Hold).
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Given the fact that so much is happening in this space, we expect investor focus on upcoming approval dates.
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