Bengaluru-based Estima Pharma Solutions which focuses on consulting services specifically to Korea and Vietnam sees that Indian pharma will be able to export only its active pharmaceutical ingredients (APIs) in the region.
There is not much scope for the finished dosage products which are generics. If there are any patented products, then Korean companies will be interested. Therefore, for Indian companies, the opportunities in Korea are mainly on the APIs and any speciality products, GG Gurudatta, CEO, Estima Pharma told Pharmabiz.
CPhI Korea which is slated to be held from August 22 to 24,2017 at Seoul, Korea is seen as a platform to fuel growth and scout for collaborations. Events like the CPhI are seen to spur the development activities for both Korea and India. Such international events encourage Korean pharma companies to go global and widen their market reach to the European Union and the US, rather than concentrate only on South East Asia and African countries. There are many companies with many products participating at the CPhI Worldwide. Some of these are now having EU GMP and US FDA approval. Whether they do business or not they will attend the CPhI events. Further, there are other events like Korea Bio, which also gives big exposure to worldwide pharma market, said Gurudatta.
On how much Korea looks at India for its strengths in qualified workforce and research-manufacture capabilities, Gurudatta said that some of the Korean companies started hiring Indian R&D professionals. But since there is a huge cultural difference, Indian people getting adjusted is difficult. Also Koreans look at Indian teams in a different way. There is no cooperation during the work and Indian professionals get discouraged he added.
The Korean R&D team’s thinking and the knowledge level is not on par with the Indian team. They are also very slow in the developments. They take 24 to 30 months for any new product developments. Also, they do not have the right experience in Quality by Design (QbD). Hence, some of the big companies are preferring Indian R&D professionals.
India and Korea have inked a Comprehensive Economic Partnership Agreement to facilitate trade and expand investments. There are many Indian companies exporting APIs to Korea. But other finished products imports and exports are limited. Some transdermal patches are exported from Korean to India.
Korea Food Drug Administration (KFDA) is slowly converting their standards to EUGMP level. They are part of PICS (Pharmaceutical Inspection Co-operation Scheme) group now. But the auditing experience is not like the inspections by MHRA, European Union or US FDA. If we have a good quality systems and infrastructure, we can clear the audits. Their approach towards Korean companies in Korea is different and therefore KFDA is liberal to the local manufacturers.
In Korea, the pharma industry is registering promising growth. They have started exporting to other countries. Some of the API companies exporting to Europe and the US are Hanmi Pharma, Estech Pharma and Kyongbo Pharmaceutical which have some good molecules. But the finished formulation exports is limited. Hardly, there are companies who have got EU GMP approval and US FDA approvals for finished dosage forms. One thing they are affected is the cost of manufacturing which is higher than India and China. There is stiff competition for the finished dosage forms in international market from India.
The minimum basic salary for any operator or workmen or QC (quality control) chemist is US$ 2,500 per month. The pharma personnel are good in certain technologies like transdermal patches, oral dissolving films among others.
An imminent trend is that Korean pharma industry is investing heavily in biosimilars. Companies like Celltrion have received considerable investment from the US to develop biotech products. The industry is concentrating considerably in these range of products, said Gurudatta.
Celltrion and Teva Pharmaceutical had announced early this month that the US FDA had accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin (INN: trastuzumab) which is used for the treatment of Human Epidermal growth factor Receptor 2 (HER2) for breast cancer and metastatic gastric cancer. In the same way FDA has accepted to review Rituximab another biosimilar product in June this year on similar lines there are many products in the pipeline for biosimilars from Celltrion. Another product Truxima is a biosimilar monoclonal antibody used in treatments of Non-Hodgkin lymphoma which is a kind of hematological cancers and rheumatoid arthritis is already launched in Europe.
Another Korean company, Samsung Bioepis which is jointly owned by Samsung Biologics and Biogen has advanced its first cohort of biosimilar candidates to regulators. Its Enbrel biosimilar has won approval in the European Union and is known as Benepali. There are other biosimilar products which are in the review stage by EMA(European Medical Agency) similar to Herceptin and Humira. Now Samsung is a competitor to Celltrion and is also developing these biosimilars through joint venture with Big pharma from the US and Europe. Samsung Bioepis, with EU-approved etanercept and infliximab biosimilars is also expected achieve a revenue target of about $872 million by 2020.
As per my understanding and interaction with Korean Pharmaceutical Association, the biosimilar market in South Korea is expected to grow about US$ 150 billion by 2019, said Gurudatta who is providing consulting services in the country, stated Gurudatta.
Korean companies are working on some new drug delivery systems like depot injections and pre fill syringes, Lyophilisation products and lyposomal delivery systems. They are working nano-technology products.
The key issues impacting Korea is with regards to generic drugs and its high cost production. The industry finds it extremely difficult to rival the competitive pricing when it exports to the US and Europe as compared to the Indian companies. Development of the NDAs (new drug applications) or Para IV filings from Korea are few because of a lack of understanding on meeting the QbD norms. This leads to the Korean pharma companies to spend more time to develop generics and this is where Indian companies have an edge, he said.
Another fact is that when Korean pharma develops the products to meet the US FDA GMP standards it is seen to be as a big challenge for them. There hardly a handful of companies which have cleared EUGMP audits and US FDA inspections. However, for biosimilars the country is way ahead of others, pointed out Gurudatta.