The Big Red Biotech Blog

Samsung Sinks Another $2B into CMO

I guess making TVs is not exciting enough. 

Samsung announced at this week's JP Morgan Conference that it would be spending another $2 B to add to its CMO facility in the Songdo Free Economic Zone in Seoul, Korea.  The multi-national giant has already built a 30,000 sq ft facility with 6 x 5000 L reactors by the end of Dec 2012.  It plans to add a further 150,000L of mammalian cell culture manufacturing capacity and 40,000L of microbial fermentation.  This would make it among the top 4 or 5 CMOs in capacity in the world.  It would be similar in capacity to Celltrion also located in the Korean enterprise zone. See Fine.

TH Kim, Samsung BioLogics CEO, says the company can exploit its construction and manufacturing expertise in this business. They have also hired experts and professionals from other CMOs in the industry to staff their new facility.  Samsung believes that it will be able to manufacture biologics (and biosimilars) at lowered costs over the competition and therefore deliver value to clients and patients.

There is no doubt that they have the financial muscle to make an impact -- assuming they can get the right staff in place to run the business.

Posted by Bruce Lehr Jan 9th 2013.

First mAb Submitted to EMA for Biosimilar Approval

A biosimilar version of Remicade (anti-TNF drug) is the first mAb to be submitted to the EMA for review.  Celltrion is believed to be the company making the submission, although this has not been formally revealed.  Celltrion has conducted clinical trials with its version of the drug in 19 countries over the past 2 years. There are 16 -- yes 16 -- approved indications for Remicade.  It is not known if Celltrion is seeking approval for only the RA indication (matching trials) or going for additional indications as well.  Extrapolation of safety and efficacy data from one indication to others is allowed potentially so it is a pertinent question.

First Monoclonal Antibody Submitted to EMA for Biosimilar Approval.

 The anti-TNF market is estimated to be worth $21 B. Analysts are torn as to whether a biosimilar version is a bigger threat to J&J's Remicade or whether a (humanized) biobetter version of the antibody will more likely prevail.  J&J has its own humanized replacment called Simponi. Celltrion is betting on gettig share however and is submitting its application well ahead of Remicade's 2014 patent expiration date. Celltrion will also go to Korea and other emerging markets in Asia and Central/South America where Remicade is not under patent.

Now, we all wait to see how Celltrion's application does at EMA.  More mAb biosimilar applications are expected to be submitted to EMA this year.  Whether these have a huge impact on the market, depends upon how easily they are approved and whether companies like Celltrion (or Samsung) can make good on their promise to drop prices by 40-50% over the reference product. The race has begun in earnest now.

Posted by Bruce Lehr May 2nd 2012.

GE Enters Turnkey Bioplant Partnership for Emerging Nations

GE and engineering firm, M+W Group, announced that they will team up on a complete biomanufacturing plant development service to serve the growing global demand in the emerging markets. The partnership will provide a single point of contact for customers, primarily governments, including IP access, financing, plant start-up, construction, and staff training. 

GE wont say if turnkey bioplant partnership will cut prices for emerging nations.

The partnership's goal is (to make money) to aid emerging nations in satisfying their unmet needs for the biological products that are predicted to have major positive health impacts. The regional focus of the partnership will highlight the Middle East, Central and Latin America, and SouthEast Asia. They will also sell to Big Pharma looking to upgrade vaccine manufacturing capabilities in emerging nations.

Posted by Bruce Lehr Dec 19th 2011.

 

Samsung and Quintiles to Join Forces on Biosimilars

Reuters and Fierce Biotech report that Samsung will invest $264 M in a joint venture with Quintiles in Incheon, South Korea to pursue biosimilars.  The venture will build a new plant for their CMO that they expect to be able to bring into production by 2013. 

Samsung executive vice president Kim Tae Han said his company hopes to generate $1.8 B in revenue from biopharmaceuticals by 2020. Samsung says it will pursue other biotech deals in 2011 and will eventually try to produce its own drugs after gaining experience through this joint CMO venture.  

Late last year, the South Korean government stated its intention to invest in the biosimilars industry.  They set the goal of achieving 22% market share of a market estimated to be $14.5 B in 2015. The government plans to provide financial and institutional support for the industry, e.g. manufacturing facilities to support biotech.  It will also name biosimilars as a "core green" industry.  Korea expects this effort to add $2 B extra to GDP, $1 B to its exports, to create 120,000 new jobs and to spawn 5 globally competitive biosimilar companies.

Looks like the biosimilars charge is coming. Samsung is getting on board.  The US government better get its funding for the US biotech industry in place sooner rather than later.

 

 

Posted by Bruce Lehr Feb 26th 2011.

South Korean Pharma Market Grows at 7.1% CAGR

Business Monitor International’s forecasts Korea's pharma market to reach almost $19.3 billion at in 2014, with a compound annual growth rate (CAGR) of 7.1%

South Korean pharmaceuticals market set to expand at 7.1% CAGR -  Pharma Letter.

The demand is predicated on an aging population with a rising demand for drugs as well as the planned liberalization of the health insurance sector. By 2019, the pharmaceutical expenditure is expected to reach $26.5 billion.

 

 

 

 

Posted by Bruce Lehr Jan 14th 2011.

Korean Government to Promote Biosimilars Industry

The Korea Herald reports that the Korean government plans to invest in supporting the biosimilar industry to make Korea a market leader. They've set a lofty goal of achieving 22% global market share by 2020.  The Ministry of Knowledge Economy says the world market for biosimilars is expected to be $14.5 B by 2015 with a huge amount of the market growth coming after a bolus of patent expirations by 2013.

Korea believes that it can be successful in taking biosimilars share by targetting price as a competitive weapon, and says that it believes biosimilars will be "easier" than innovative products as the R&D requirements will be lessened in comparison. 

"The local [Korean] generic pharmaceutical industry failed to advance to the global market because it just settled for the domestic market. We need to make this an opportunity for Korea to become a leader in the global bio and pharmaceutical industry,” said Minister of Knowledge Economy Choi Kyung-hwan at a meeting with chiefs of local pharmaceutical firms.

The government plans to provide financial and institutional support for the industry, e.g. manufacturing facilities to support biotech.  It will also name biosimilars as a "core green" industry.  Korea expects this effort to add $2 B extra to GDP, $1 B to its exports, to create 120,000 new jobs and to spawn 5 globally competitive biosimilar companies.

It looks like they plan to make a serious run at biosimilars and have thrown down the gauntlet to all other competitors.

 

 

 

 Posted by Bruce Lehr November 22nd 2010.