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Executive Summary

Biocad has made significant strides in Vietnam with its biosimilar rituximab, and an anticipated “permanent registration” there is expected to unshackle limitations on imported supplies of the product. The Russian company tells Scrip that it is also planning to build its biosimilars presence in other Asian markets.


Russian biotechnology company Biocad appears to be on course to substantially expand the supplies of its biosimilar rituximab in Vietnam, a market that it has been engaged with since 2015. Biocad’s rituximab is a biosimilar of MabThera/Rituxan and innovator Roche is a dominant player in Vietnam.


The Russian firm said that last month it had been permitted to supply rituximab to Vietnam for a second time – implying continued access to its product at Vietnamese hospitals via the Russian company’s local partners.

But Biocad now expects to receive a permanent registration certificate for the medicine at the end of the third quarter or beginning of the fourth quarter of 2017, a move that is expected to facilitate export of the product to Vietnam from Russia “without any limitations”.

Limits To Be Lifted

Biocad told Scrip that while a permanent registration (as well as quotas) gave the company “no preference” for supplies in Vietnam, the current quota for rituximab means that the company can import only limited amounts into the country.

“After obtaining a permanent registration, we will be able to bring in the drug in accordance with the hospitals' need for rituximab. If there is a demand from Vietnamese hospitals, we can assert our supply capacity and provide as much drug product as needed,” Biocad explained.

However, the Russian company did not want to be drawn into a direct price comparison with the innovator product, since Vietnam’s complex five-step procurement system makes such specific comparison difficult.

“Currently, Biocad and Roche participate in tenders in different [product] groups, and thus talking about the price difference is meaningless,” Biocad declared. But it did underscore the “high quality” of its biosimilar, which it said had been proven in sizeable multinational clinical trials.

The Russian firm’s other products, such as biosimilar bevacizumab, are already available in Vietnam and supplied to many leading medical institutions there, while it expects its version of trastuzumab to be marketed later this year.

No ‘Direct Obstruction’

Biocad also indicated that it does not anticipate any “scare tactics” by Roche in Vietnam, as has been alleged in the past in other markets like Sri Lanka for trastuzumab and bevacizumab.

Biocad and Roche were earlier at loggerheads in Sri Lanka after the Russian company’s partner there was apparently at the receiving end of what it claimed were the Swiss multinational's tactics against biosimilar competition in the island market. A Court of Appeals of Sri Lanka at the time dismissed Roche's claims questioning the local marketing authorizations for Biocad's trastuzumab and bevacizumab.

In Vietnam, Biocad said that it had not faced “any direct obstruction yet” but maintained that competitors might try to prevent the company entering the market by “providing inaccurate information”. It anticipated no disturbance as long as the company does not compete with Roche in the same product group within Vietnam’s drug procurement system.

Vietnam has three key tender product categories - innovator drugs, generics, and traditional/herbal medicines. For the procurement of generics, there are five sub-categories including “Package One” for drugs manufactured at EU-GMP or Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)-GMP facilities in International Council for Harmonization (ICH) countries, or medicines manufactured at World Health Organization-GMP facilities certified by Vietnam’s Ministry of Health (MoH) and having marketing authorizations from ICH countries, notes an update from Tilleke & Gibbins, a regional law firm in Southeast Asia.

Category Two includes drugs manufactured at EU-GMP or PIC/S-GMP facilities not in ICH countries, while Category Three is for drugs manufactured at WHO-GMP facilities certified by Vietnam’s MoH. The fourth category pertains to drugs having evidence of bioequivalence, as announced by the MoH, while Category Five is for drugs other than those in the first four categories. Any recent revisions to these norms, if any, could not immediately be ascertained.

Other Expansion Plans

Biocad is also working on the further international expansion of sales for its rituximab biosimilar, and the product is already available in certain markets in Southeast Asia, the Middle East, and CIS countries, it said. By the end of 2017, the company expects its rituximab to be available in India and Sri Lanka as well.

“We expect the authorization documents as early as this year. The registration status for rituximab in India is in the same stage,” Biocad noted.

Although Biocad works with a partner company for the Sri Lankan market, in India it plans to market its products independently via a representative office.

Asked how critical the Asian market is to Biocad’s revenue growth, the company said that that the region has “equal priority” for the company as the MENAT (Middle East, North Africa and Turkey), LATAM (Latin America), the CIS, and European markets.

“Biocad has a solid foundation and is financially solvent. Our goal is to promote affordable products of high quality by extending our global presence and to make effective and affordable drugs for patients in the Asian region,” it added.

It also referred to commercial sales in Latin America, Africa, South East Asia, among other markets, that have sometimes expanded the availability of rituximab to as many as “four times more patients” than for the original product alone.

“The price of the reference drug has been forced down and Biocad has also been unafraid to go to the courtroom to challenge Roche where it has felt the pharma giant was acting improperly,” the Russian company told Scrip.

In the next two to three years, Biocad expects revenues from Asian markets to contribute about 5-10% of the company's total. In the next five years, revenue from international markets is expected to account for fully half of the company’s overall sales, it added, but gave no specific numbers.

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