Drug makers continue to invest big in the biosimilar space, which has led to a rapid development of a new class of copycat drugs. Copycat drugs offer cheaper alternatives to costly biologics and are emerging as a promising revenue stream for the future.
Taking note of the emerging trends, U.S. regulators have not only approved four biosimilar drugs, two of which are already on the market, but also issued key guidelines recently regarding the drug class. (For more, see FDA Issues Guidelines for Biosimilar Drug Naming.)
Investopedia looks at the top four drug makers that hold potential for the near future. (For more, see Biosimilar Drug Competition Heats Up in 2017.)
Top Biosimilar Drug Companies
Novartis AG (NVS) takes pride in securing the first biosimilar approval in 2015 from the U.S. Food And Drug Administration (FDA) for Zarxio, a biosimilar of Amgen Inc.’s (AMGN) Neupogen (filgrastim). Last August, it also secured approval for Erelzi, a biosimilar to Amgen’s Enbrel (etanercept). (For more, see Friends or Foes: Amgen and Novartis.)
The company has four more key biosimilars in pipeline, the copycats of Humira (adalimumab), Neulasta (pegfilgrastim), Remicade (infliximab) and Rituxan (rituximab), which are expected to hit the markets by 2020. Combining Enbrel, all five drugs clocked annual sales of around $45 billion, and if Novartis’ copycats can capture even a small slice of the pie, its revenues could balloon.
Amgen secured approval for Amjevita, a copycat of bestseller anti-inflammatory treatment drug, AbbVie Inc.’s (ABBV) Humira. (For more, see Amgen's Biosimilar Gets FDA Approval.) In partnership with Allergan PLC (AGN), it also filed for Roche’s Avastin (bevacizumab) biosimilar called ABP 215 (For more, see Amgen, Allergan Unveil Avastin Copycat.). The two companies are partnering to develop three more oncology biosimilar drugs.
Biogen Inc. (BIIB) does not have its own biosimilars on the market, but its marketing deal with Korea-based Samsung Bioepis helped it garner revenues from the European biosimilars market. It markets Benepali, a copycat of Enbrel, and Flixabi, a copycat of Johnson & Johnson’s (JNJ) Remicade (infliximab) in the EU. With the company acting as a contract manufacturer for Samsung Bioepis, and also having option to buy up to 49.9% of Bioepis, it has the potential to reap significant profits from biosimiliars in the future.
Merck & Co. Inc. (MRK) works similarly to Biogen in the biosimilar market. It partnered with Samsung Bioepis to develop MK-1293, a copycat of Sanofi’s (SNY) Lantus, which is submitted for approval in the U.S. and EU. It also has rights to Bioepis’ biosimilars of Enbrel, Humira, Herceptin, and Remicade (ex-EU), primarily in the U.S.