A month after Mylan ($MYL) and Biocon saw the EMA accept their marketing application for a copycat version of Roche’s ($RHHBY) major blockbuster cancer med Herceptin (trastuzumab)--the first to do so--Samsung Bioepis says it too has now notched that regulatory milestone as the companies race to market.
This means the EMA will now begin to assess their version of the Swiss major’s breast cancer med, which Samsung Bioepis says comes after it delivered its application back in August for its biosim candidate, known as SB3.
The company is part of South Korea's top conglomerate Samsung Group; Biogen ($BIIB) also owns around 8% of the company. SB3 is now Samsung Bioepis' fifth biosimilar candidate submitted to the EMA, following SB4, a copy of Amgen’s ($AMGN) Enbrel (etanercept); SB2, a biosim form of Janssen’s ($JNJ) Remicade (infliximab); SB9, its version of Sanofi’s ($SNY) diabetes med Lantus (insulin glargine); and SB5, a copy of AbbVie’s ($ABBV) major seller Humira (adalimumab).
Both SB4 and SB2 have now been approved on the continent.
Its Herceptin copy is in fact its first cancer biosimilar candidate submitted for regulatory review in Europe. Should it be approved, partner Merck ($MRK) will handle the marketing and distribution of the med in Europe.
“Trastuzumab remains vital in treating breast cancer, the most prevalent form of cancer affecting women across Europe,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis.
“If approved, we hope our affordable, high-quality medicine will help realize the promise of biosimilars for breast cancer patients across Europe by widening patient access to this important, life-enhancing treatment option.”
Roche's EU patents on Herceptin expired in 2014, but it remains the Swiss group's third-biggest drug with sales of CHF 6.5 billion ($6.6 billion) last year, CHF 2 billion of that total coming from the European market. It made $3.49 billion in total for the first half of 2016.
Late-stage data for Biocon and Mylan’s rival biosimilar MYL-1401O were posted earlier this year and showed it achieved the same overall response level as Herceptin after 24 weeks of therapy.
Mylan and Bangalore-based Biocon first launched their biosimilar trastuzumab in India in 2013, prompting a legal dispute with Roche over label claims. The two partners followed India up with launches in other emerging markets.
Meanwhile, Celltrion also has a Herceptin biosimilar on the market in South Korea, where it is known as Herzuma, but has not yet filed for EU approval of the drug.
Back in July, Amgen and partner Allergan ($AGN) reported positive top-line Phase III data for their Herceptin biosimilar, showing that it was noninferior to the original drug.
Dan O'Day, CEO for Roche Pharmaceuticals, recently played down the immediacy of the threats coming from these companies, saying in July that “At this stage the main exposure for our business would certainly be more in 2018 than 2017 [from a Herceptin biosimilar].”
Samsung BioLogics, the parent company of Samsung Bioepis, also separately announced today that its intended IPO will see it sell 16.5 million shares and could raise as much as $1.7 billion to $2 billion, according to the Wall Street Journal.