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[영문] Vol. 91 (August 5, 2019)

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작성일 2019-08-05 16:43:15
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A Biweekly Updated Biopharmaceutical News Service

National Assembly Pass a Bill, "Advanced Biopharmaceuticals"

The Act on the “Safety and Support of Advanced Regenerative Medical and Advanced Biopharmaceuticals” (hereinafter Advanced Bio Act) was eventually passed at the National Assembly on 2^nd August 2019. We have been expected the law to strengthen the global competitiveness of the K-bio industry long before legislated.

The Act allows separation of the advanced biopharmaceutical products from the scope of control by the existing Pharmaceutical Affairs Act, the Blood Management Act, and the Bioethics Act. It aims to establish systematic frameworks to be aligned with bioengineering development which is evolving at a superhigh speed.

The government and industry expect to attain two goals at once of quickly responding to the unmet medical demands by the legislation and improve the national health and to develop the biopharamceutical industry as well.

Key Details of the Advanced Bio Act.

The definition of the advanced regenerative medicine and the advanced biopharmaceuticals
Priority Review Process: Priority review of the innovative biopharmaceutical products injected to diseases without any other treatment measures than other medicinal products
Customized Review System: Conduct prior screening in phases by receiving the documents required for licensing in line with the sponsors’ timeline
Conditional Approval: If the product is proof of its effectiveness, allow commercial sales of the medical products with phase 2 clinical trial on the condition to conduct phase 3 clinical trial to improve the treatment opportunities for the patients.
* Therefore, the industry expects the law to shorten the time to access its market for advanced biopharmaceuticals by up to four years.

Prepare reasonable safety control measures for the advanced products connected with innovative technologies including heterogeneous organs and stem cells, API safety control system and measures to strengthen the quality control measures of the full lifecycle from manufacturing to prescription.

The Act shall be enforced one year after the Presidential proclamations. Korea Biomedicine Industry Association which has made efforts to establish the advanced bio Act framework shall engage in supporting the MFDS in legislating the enforcement Act to serve its role to incorporate the opinions and status of the biopharmaceutical industry.

Status of Pharmaceutical Market in Korea in 2018

In 2018, the export of pharmaceutical products recorded USD 4.67bn, the highest ever. Biopharmaceuticals record trade surplus for 4 consecutive years!

1) The biopharmaceuticals are strong in export performances recording trade surplus for 4 consecutive years

The trade surplus in biopharmaceutical products export marks 380.4 bn KRW
※ Overall pharmaceuticals trade is 2.121 tn KRW in deficit

2) The biopharmaceuticals take up top production results in both finished drugs and API

Finished pharmaceutical goods:
(1^st ) IV GLOLULIN SN INJ 5% (GC Green Cross, plasma derivatives)
(2^nd) Meditoxin Inj (Meditox, Botulinum Toxin)
API(Active Pharmaceutical Ingredient):
(1^st) Herzuma undiluted solution (Celltrion, recombinant protein product)
(2^nd) Truxima undiluted solution (Celltrion, recombinant protein product)
(3^rd) Remsima undiluted solution (Celltrion, recombinant protein product)

3) The 2018 medicine export performance recorded the highest result in its history,
in which biopharmaceuticals accounted for 33%

Overall medicine export of USD 4.67311 bn (5.1431 tn KRW)
Biopharmaceutical products USD 1.55925 bn (1.7161tn KRW)
Biopharmaceuticals export result for the past 5 years (2014~2018) is recording an annual average growth of 27.6 %, maintaining a high growth rate
※ The biopharmaceutical production accounts for 1/10 of the total pharmaceutical products but takes up 1/3 of the export