Now, the therapeutic agent that can be used for intractable diseases and unmet needs that have been approved, bio-pharmaceuticals has become a center, high production and development costs, because the greater the treatment of the burden, the product of a small amount of multi-item in Japan, inexpensive efforts rapidly production capable technology development has begun. It also has become active development of biopharmaceuticals. In addition, the drug called dramatically elevated bio Better a by applying leverage the gene modification techniques and sugar chain-related technology activity and the like is, Ri by the reduction of administration, and the like amount and frequency of administration, health care costs savings, convenience · QOL it is said that there is a high possibility of being able to contribute to the improvement of. However, in the development of these medicines, rational CMC (Chemistry, Manufacturing and Control) and that and safety evaluation method is not yet determined, of thrombopoietin-related drug adverse reaction of development stop and erythropoietin receptor affinity peptides by as of the market after the recovery in the US due to fatal hypersensitivity reaction, reality is such that there is no suitable animal model in safety assessment has become an issue.

Bio Development of OMD 　investment in the bio-drug discovery it is important to think in a wide field of view.

Domestic biopharmaceutical growth will answer to the expectations, we especially growth of "antibody drug" is is expected to be double-digit growth prominent 2015.
Among the general of the drug is pushed to generics, for now starting biopharmaceutical seems not so much influence the subsequent development products. In November 2014 biosimilars for the first time of "antibody drug" in Japan have first appeared in the country.

If sales of biosimilars long as the growth in the starting lineup, is one of the features that extend both. However, for now, maker of Shimira sales Nippon Kayaku Orazu is the E has a large presence at the moment, on the other hand the starting lineup maker is Mitsubishi Tanabe Pharma of arthritis remedy "Remicade" will continue even after the appearance biosimilar It is strong.

Under these circumstances, and eventually more than 40 trillion yen medical expenses of Japan in September of this year, a follow-switching of medicines became a priority. Incentive is strengthened, including the Shimira also as a policy of the government now. 2016, health systems of developed countries biopharmaceuticals in sales top 10 items in the world of pharmaceutical products accounted for 7 item has become a situation that does not forced to forced Koze a somewhat of treatment for expensive biopharmaceuticals.
Soredakeni expectations of biosimilar for the biopharmaceutical to the off-patent is growing.

The problem with government thinking and BIO 

Generic from the government Dasa a new target of 80% in 2020, after the generic coefficient of DPC hospital has been established, category change to switch the long-term listed drugs to generic has progressed rapidly. Sales of generic companies continued to high growth, on the other hand, block buster in the age of low-molecular-weight drug in the original drug market has already came to an end. Biopharmaceuticals shown significant growth, we have increased the presence in the pharmaceutical market.
GE market expansion due to the patent expirations of low-molecular-weight large pharmaceuticals have become already difficult in the entire developed countries, as one of biosimilars is a trump card of medical and drug cost containment, also of low molecular pharmaceutical generics and plateau interest of the pharmaceutical industry is growing as a new pillar of after becoming.

On the other hand, the biosimilar has been pointed out also a problem not in the conventional generic drugs. One of which is the effect of the system to reduce the burden on the patient, such as high medical expenses. Is a good system, but this system has a surface on which to lose the patient's choice you want to find a cheaper drug, it is also the factor that prevents biosimilar spread. Also, is it is How You take position is a large challenge in the starting lineup of bio-pharmaceutical products. 70% of the drug price of the starting lineup is also the difficulty of cutting even. Furthermore, since biosimilars is a complicated large structure is molecular weight, it is difficult to show the identity of the starting lineup bio products, clinical trials to verify the equivalence-homogeneity in the quality, safety and efficacy such as are required, it is also one of the hurdles is large burden in terms of cost for the pharmaceutical manufacturers.

Of course Among such an environment, there is a good way to lower the hurdle.  

Biosimilars 　(generic name of the drug, which was prepared by similar to the new drug of the preceding manufacturer after the expired patents of pharmaceutical products derived from bio-based)

Preceding bio-chemicals and equal, the quality of the same quality, safety, efficacy as a drug having the different vendors is a drug to be developed by. That is leading biopharmaceutical and quality, equivalence obtained from comparing the safety and efficacy, homogeneity can be developed while on the basis of the data that shows.

Bio-Better

Plus the improvements to the existing bio-pharmaceuticals, but are similar to existing products, different things of that the existing products enough to approval as a new biopharmaceutical in the existing institutions. In the simplest terms, a "bio-better", not dramatically change the physical properties even while improving the safety and effectiveness of biologics.

For the introduction of production and the introduction of product biosimilars

A huge investment in the construction of new production facilities, the period of up to running, the difficult recovery of capital investment, such as personnel ensure is that everyone I think.
So OMD is introduced and contract manufacturing from overseas, drug purchase, we will propose a reduction in development costs by the international clinical trials.

Currently, we offer a wide range of developed products of the OMD currently 14 items.
New Biologic, Bio Better, Bio similar (Approned, Non clinical, Ph2.3, ProcessDevelopment)
for example, G-CSF (Bio Better), Avastin, Rituxas, Enbrel, Remicade, Herceptin etc.

Biosimilar drug prices　 drug prices set of ideas biosimilar is, in the first place is intended to commercialization in the region where the generic can not appear, there is a need for clinical trials such as the verification of the equivalence / homogeneity of the preceding biopharmaceutical the cost required for this from the fact, evaluated, in pricing the drug price calculation of generic products (the original drugs × 0.7) as the base, and Jojo (within 10%) a certain percentage.

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Samsung Bioepis Co., Ltd., respectively, etanercept and infliximab SB2 trial biosimilar candidate of SB4, announced that it has to maintain the same safety profile in clinical trials of 52 to 54 weeks.

JPMA BIO-related　"human resources shortage of biotechnology is a problem," May 16, 2016 [priority issues] 　biopharmaceuticals committee of the Japan Pharmaceutical Manufacturers Association 16 days, held a meeting in Tokyo, as this year's priority issues, Japan through cooperation with the medical research and development mechanism (AMED), to determine the policy to tackle such as the grant of human resource development related to the development of bio-pharmaceutical manufacturing technology. 　Mr. Junichi Koga was appointed the new chairman (Daiichi Sankyo) is, in the conference after the meeting, "shortage of biotechnology is a challenge, I want to support the development of human resources as a JPMA," he stressed. Also this year, in the bio-pharmaceutical manufacturing base of GMP compliance in Kobe, I was talking to the intention that you want to start the project to continue to nurture young talent. The committee of listed this year's priority issues and countries of biopharmaceutical related measures on the trends grasp and related measures for the proposal , biopharmaceutical manufacturing and marketing approval application Matters "Creating a mock-up" research and study of (CTD) Bio comparison with overseas relates to a formulation additive of pharmaceutical efforts to regulations and systems-related issues surrounding the investigation, research and vaccine of-regenerative medicine and cellular therapy particularly for industrialization of bio-pharmaceutical products, there is a delay of infrastructure compared to Western , promoting development and infrastructure development of bio-pharmaceutical products has become one of the future of the industry measures.