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 2nd
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:
(1st ) IV GLOLULIN SN INJ 5% (GC Green Cross, plasma
derivatives)
(2nd) Meditoxin Inj (Meditox, Botulinum Toxin)
API(Active Pharmaceutical Ingredient): (1st) Herzuma undiluted solution (Celltrion, recombinant
protein product) (2nd) Truxima undiluted solution (Celltrion, recombinant
protein product) (3rd) 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)
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
4) In particular, biosimilar export accounts for 23% of
the total pharmaceutical export Potential to grow to a
prosperous export industry