Biosimilars are a relatively recent development in the pharmaceutical industry, meaning market penetration is still fairly low, even in many developed markets, much less emerging markets. Prior to 2019, not a single biosimilar had been approved in China. However, a McKinsey analysis found that biosimilars could account for a growing share of sales in emerging markets, projecting double-digit growth annually for key emerging markets from 2018-2025. In particular, they estimate that the biosimilar market in China might quadruple from USD 2 billion in 2018 to USD 8.1 billion in 2025.
22 February 2019 marked the momentous occasion of the first biosimilar approval in China, developed by local biotech Henlius. HLX01 is a biosimilar of Genetech/Roche’s best-selling cancer drug Rituxan. Rituxan was the first ever monoclonal antibody the US FDA approved for cancer and generated USD 4.3 billion in sales in 2018 – also the year in which it lost exclusivity in the US market. In Europe, the loss of exclusivity came five years earlier in 2013, with correspondingly significant declines in sales. Fortunately for the Swiss drugmaker, these losses have been somewhat offset by significant gains in the China market. In 2017, Rituxan’s China sales were estimated at USD 258.6 million according to IQVIA data.