Which Biosimilars Will Upend the Global Market in 2017?

Biosimilars are absolutely a hotspot of the global pharmaceutical R&D field in recent years, especially in the patent cliff era. There have been biosimilars sold in the Europe since 2006, but the U.S. did not fill in gaps in system of relevant regulation of biosimilar approval until 2010. Biosimilars have developed more smoothly in the Europe. However, increasingly more biosimilars have formally occupied the U.S. market since the emergence of the first biosimilar Zarxio (biosimilar of Amgen’s Neupogen) in the U.S. market. What are the biosimilars that will change the U.S. pharmaceutical market pattern or even upend the global pharmaceutical market in 2017?

EvaluatePharma has forecast the global top 10 drugs by 2017 sales recently, wherein, seven will be subject to the direct impact of biosimilars.

Global Top 10 Drugs by 2017 Sales (source: EvaluatePharma)

Sanofi’s Lantus (insulin glargine) will be the first to be affected, with the annual sales estimated to decline from the about USD 6.3 billion to about USD 5.2 billion and the ranking unchanged. The large decrease of the sales will be mainly due to the influence of the new marketing of the biosimilar Basaglar of Eli Lilly and Boehringer Ingelheim. Basaglar has the same amino acid sequence with Lantus, and is used through the prefilled Basaglar KwikPen; it is a kind of long-acting insulin used to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes and cannot be used to treat diabetic ketoacidosis. Eli Lilly and Boehringer Ingelheim plan to make the sales of Basaglar hit USD 4 billion. The biggest attraction of biosimilars lies in the price advantage. The biggest pharmaceutical product retailer CVS in the U.S. has announced to replace Lantus with Basaglar in 2017. Furthermore, Merck also has launched the biosimilar of Lantus. As a result, it is almost undoubted that the market of Lantus will be gradually nibbled.

The blockbuster brand drug Remicade (generic name: infliximab) of J & J will also be much impacted by the biosimilar infliximab-dyyb (trade name of Pfizer: Inflectra, trade name of Celltrion: Remsima). As the first monoclonal antibody (mAb) approved by EMA, Inflectra was originally co-developed by Hospira and Celltrion, and Pfizer succeeded the exclusive commercialization rights of Inflectra in the U.S. market after it acquired Hospira for USD 17 billion in 2015. Before this, they had succeeded in bringing Inflectra to other markets in the world. Regarding price, Inflectra is 15% cheaper than the brand drug Remicade. Pfizer expressed that Inflectra would help the U.S. patients access an additional high-quality treatment option that promises greater savings for the U.S. healthcare system. A Bernstein analyst estimated the market share of the biosimilar Inflectra would exceed 50% at the end of this year, and J & J’s hope to obtain USD 5.9 billion from Remicade may fail.

In the meantime, Enbrel’s biosimilar of Sandoz under Novartis has been approved by FDA, however, Amgen is still stopping the marketing in a patent court. The Bernstein analyst forecast that Enbrel’s biosimilar would account for one-third market in the Europe. In addition, the three best-selling products of Roche: rituximab (Rituxan), bevacizumab (Avastin) and trastuzumab (Herceptin) are separately the third, fourth and sixth on the list of global top 10 drugs by 2017 sales, all of which will face the biosimilar competition in next few years.

The most notable biosimilar will be the generic drug of the drug king Humira. According to the forecast of EvaluatePharma, the sales of Humira will reach USD 17.6 billion in 2017, and not surprisingly, will still be the drug king. According to incomplete statistics, Humira’s biosimilars in development reach more than 20, wherein, the Humira biosimilar Amjevita (adalimumab-atto) of Amgen was approved to go to the U.S. market in September 2016 for treating multiple inflammatory diseases. Amjevita is considered by FDA to be Humira’s biosimilar instead of interchangeable product. However, biosimilars will not truly shake the drug king status of adalimumab (Humira) until 2018, according to a relevant analysis institution.

According to forecast of IMS Health, the annual sales of biosimilars are expected to reach USD 25 billion in 2020, accounting for 10% market share of biological drugs. FDA approved 3 biosimilars in succession in 2016, separately corresponding to the super blockbuster original biological drugs Remicade (infliximab), Enbrel (etanercept) and Humira (adalimumab). These 3 approval cases offer much experience for experience to more enterprises conducting layout in biosimilar R&D.

About the author: Caicai, a Master of Pharmacy from Shanghai Jiaotong University, ever worked in an institute for scientific and technical information, currently a practitioner of the drug administration system, good at interpreting industry regulations and latest drug research dynamics, etc.