Samsung Bioepis readies assault on EU Herceptin market

Samsung Bioepsis

Samsung Bioepis has submitted a biosimilar version of Roche's breast cancer blockbuster Herceptin in the EU, hard on the heels of rivals Biocon and Mylan.

The two competitors are pitching for a slice of the brand's $2 billion-plus sales in Europe, which is regarded as a particularly fertile market for biosimilars thanks to several years of experience with the copycat products.

Roche lost its main patent on Herceptin in Europe in 2014 after losing a patent dispute with Hospira, but two years later the brand still isn't facing biosimilar competition outside emerging markets such as South Korea, India and Russia.

The reasons for the delay in filing for approval of Herceptin biosimilars in Europe have been debated for quite some time, although the developers of the drugs have stayed tight-lipped. One reason could be that the European Medicines Agency (EMA) has set a high bar for equivalence studies, including demanding data in early-stage as well as advanced breast cancer patients.

Samsung Bioepis has revealed that it actually filed for EU approval for its SB3 biosimilar in August, at around the same time as Biocon and Mylan filed their candidate, which suggests that they could hit the European market at around the same time if approved. 

Meanwhile, Celltrion and Pfizer's Hospira unit are also said to be preparing to file for approval of their own versions of the big-selling brand, while Allergan and Amgen have a Herceptin biosim in late-stage testing.

If it reaches the EU market, SB3 will be sold by Merck & Co. (known as MSD in Europe) and--if prior experience with biosimilars of other drugs such as Remicade is an indication--Roche could be facing a sizable erosion in European sales in 2018. Merck reported unexpectedly severe sales declines for Remicade in the EU in the first half of the year. 

For Samsung Bioepis--a joint venture between Samsung BioLogics and Biogen--the Herceptin clone is its first cancer biosimilar to be submitted in Europe. 

It has already bagged approval for copies of Amgen's Enbrel (etanercept) and Janssen's Remicade (infliximab)--sold by Biogen as Benepali and Flixabi, respectively--and has applications under review in the EU for versions of AbbVie's Humira (adalimumab) and Sanofi's Lantus (insulin glargine).

News of the latest filing came as Samsung BioLogics published yet another update on its long-anticipated initial public offering, part of a strategy aimed at catapulting it to the top of the biologics contract manufacturing sector.

The company said this week it plans to sell 16.5 million shares at 113,000 to 136,000 won (roughly $102-$123), which would net $1.7 billion to $2 billion. That represents a bit of a reduction from its earlier estimate of up to $2.6 billion but still represents one of South Korea’s biggest-ever IPOs.

Samsung BioLogics said it will use the proceeds of the IPO to expand its manufacturing capacity and to invest in R&D aimed at improving biologic drug production.

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