China, the last frontier: IBSA’s much-anticipated return to the market

China, the last frontier: IBSA’s much-anticipated return to the market

09 July 2020

How long does a market launch in China take? Is it difficult or does it require special effort? More importantly, how much is it worth positioning oneself in the Chinese pharmaceutical industry? Bringing one or more products to the Chinese market may indeed require commitment, but it could have a very satisfactory outcome in terms of development and business.

“IBSA managed to launch in China in 2009 and obtained a 10% market share in four years. There’s no use hiding it; re-launching onto the Chinese market has been a painful experience and it has taken a long time to get the go-ahead from the Regulatory Authority” - says Carmen Giordani-Vigorelli, Senior International Sales Manager, about FSH, a follicle-stimulating hormone indispensable in infertility treatment. “We’re not entirely sure whether it was a problem with compiling the dossier or simply due to different local regulatory requirements. All sorts of things happened during the process, but the story finally has a happy ending!” - adds Daniela Mariano, Senior CMC & Regulatory Affairs Manager.

“IBSA as a company operates in various countries and at a regulatory level it continually interfaces with different regional contexts,” continues Daniela Mariano, “Requests to register in China are particularly complex and the typical requirements are not always in line with those of the rest of the world, but we’ve worked hard and the example of FSH came as a result of excellent teamwork that responded effectively to Chinese regulatory requests.”

The satisfaction that comes from completing an incredibly demanding process is also and above all due to the development expectations linked to IBSA’s presence in China. With the approval of the Chinese Regulatory Authority, a long-term strategy is being perfected.

“The lengthy and nerve-wrecking regulatory process, during which IBSA never gave up, is now complete. Among other things, in China a major part of production is concentrated in our fertility department,” continues Carmen Giordani-Vigorelli.

China is one of the biggest markets in the world, with a trend of increasing demand. We must not forget that until 2013 the one-child policy was in force in the country. Today, with the abolition of the legislation and continuing economic development, the desire for parenthood has grown, including among older people who wish to enlarge their family or start one for the first time.

There are various competitors, but over the years IBSA has managed to position itself among the main companies in the field of fertility treatment. “Through collaboration with a very strong local Chinese distributor, we will finally bring FSH to the market. From September to November 2020, we’ll send 100,000 vials per month, then there will be an official launch and the actual marketing will begin.”

It is not the only market IBSA, which is currently concentrated in Europe and other non-EU countries, is looking to expand its positioning in, however. “One of the major focuses is the market in South America, but Asia is also a continent on which we have not yet managed to plant our flag,” concludes Carmen Giordani-Vigorelli, “and this is why the green light obtained in China makes us particularly optimistic. Given this excellent favourable outcome, we can now focus our efforts on obtaining new registrations to expand the IBSA product range in China. Let’s hope the process will be a little shorter this time!”

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