June 11, 2018 Sophie Ferronato

China has its eyes on biosimilars

Pricentric Brief: China has its eyes on biosimilars

by Sean Skulski

 

  • Roche’s Herceptin is experiencing a shortage in China due to swift uptake of the drug following China’s implementation of a new health plan
  • While Herceptin biosimilars are finding traction in the US and Europe, China has yet to receive access to any copycat products
  • China is adamantly paving the way for biosimilars to reach its market, implementing new pathways, policies, and guidelines to ignite manufacturing and production
  • Ultimately, it seems as though China will prove to be a biosimilar powerhouse

 The Details

A shortage of an originator

When Roche’s Herceptin (trastuzumab) ended up on China’s national health insurance, the drug’s manufacturing facility was overwhelmed. Now, China is experiencing a shortage of Herceptin, and Roche received approval to transfer production to a much larger, higher-capacity plant.

Last July, Herceptin, along with Roche’s Avastin (bevacizumab), Rituxan (rituximab), and Tarceva (erlotinib), was added to China’s National Reimbursement Drug List (NRDL). At the onslaught, 44 drugs were in question, but ultimately, 36 were added to the NRDL because these products were offered to China at significantly discount rates, with Herceptin being the most generous at a 70% discount.

According to data from Pricentric One, Herceptin Infusion 1 Lyophilized Powder Vial 20 ML 440 MG costs an MNF price of 2,547.48 USD (16308.46 yuan).

In turn, the drug experienced an unexpectedly rapid uptake. The hasty hike was due in part to the implementation of a new health plan by China’s Ministry of Human Resources and Social Security (MoHRSS). Herceptin was accessible within three months, whereas in the past, new drug uptake followed a notoriously lengthy process.

The MoHRSS was ecstatic to note that China’s drug prices were lower than in surrounding markets. Moreover, the agency asserted that the generous, negotiated rates “…greatly reduced the burden of medical expenses on patients.”

After Roche’s magnanimous offer, the Swiss pharma saw a slower incline in sales (11% decline from the first half of 2017), but as more consumers gain access to the drug, Roche expects profit escalation once again.

 

Herceptin biosimilars

Currently, Herceptin is the only available form of trastuzumab in China. Unlike China, the EU and the US have seen a spike in biosimilar uptake. The EU has been more stalwart towards biosimilars, approving over 40, but multiple biosimilar manufacturers are applying for FDA approval in the US.

Mylan, along with India’s Biocon, has Ogivri, a Herceptin biosimilar, which found approval in the US. In the EU, Merck’s Herceptin biosimilar Otruzant, which is manufactured by Samsung Bioepis, received EMA approval in 2017. Pfizer’s Trazimera, Cellitron’s Herzuma, and Amgen and Allergan’s Kanjinti have received positive recommendations from the European HTA body as well.

 

The biosimilar-scape of China

Price-conscientious China is craving biosimilars; with Herceptin as its only option for trastuzumab, it’s no wonder that China is looking to biosimilar products to add to the NRDL.

According to the Swedish Agency for Growth Policy Analysis, many biological products have been unobtainable to Chinese citizens, despite income growth and a burgeoning middle class; therefore, with the advent of biosimilar guidelines, biosimilars are expected to hit the ground running due to their low costs compared to the originators.

Moreover, China has begun to develop more biological products, as well as biosimilars; in fact, the agency notes, “Some Chinese firms are today developing biosimilars that can be marketed at a price level of around 40% of imported alternatives.” Though intranational production signifies lowered costs, “A challenge to Chinese drug firms is the price of the brand named biologic drugs that they seek to develop a version of. This is especially a barrier to small companies with limited financial capacity.”

 

China’s move towards biosimilars

China’s Center for Drug Evaluation (CDE) released its much-anticipated guidelines for biosimilars in 2014. At the time, the guidelines were only applicable to therapeutic recombinant protein products consisting of clear structures.

Overall, the guidelines and definitions employed by CDE reflected those in Europe. The reasoning behind this was to ensure that pharma would not be wrought with new, matrix-like rules and regulations while seeking China’s approval—the process would be familiar. In turn, China would access new biological products with ease.

The establishment of other, new approval pathways and the implementation of new policies to promote research and development has positioned China for future success in biosimilar manufacturing and commercialization. Most notably is China’s recent implementation of “Priority Review” legislation that offers clinical trial application for generic drugs submitted three years before patent expiration or manufacturing applications for generic drugs one year prior to patent expiration.

It is expected, though, that China will get its hands on expired patents—and there are four major drugs with patents due to expire in China within the next few years—to manufacture biologic products to its domestic population before further international expansion.

As of now, China has yet to officially greenlight a biosimilar, though Fosun Pharma’s Rituxan biosimilar recently went under priority review, making it the first Chinese-developed biosimilar to apply for listing. It’s expected to be the first biosimilar to reach the Chinese market.