Boehringer to create biosimilars division (original post in www.inpharm.com)

Another post on biosimilar business initative... by Boehringer Ingelheim.
The original post can be found at http://www.inpharm.com/news/168064/boehringer-biosimilars-division
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Boehringer Ingelheim is to tap into the growing interest in biosimilars with the creation of a division dedicated to that market. The new venture, which the manufacturer says will be a separate business, is tasked with developing and commercialising Boehringer’s own biosimilars.

“We believe that biosimilars will become a major part of the biopharmaceutical market and will enable many more patients access to important medicines,” explained Wolfram Carius, member of Boehringer’s board of managing directors.

“We feel confident that we are able to leverage our capabilities in product development, supply and clinical expertise at Boehringer Ingelheim to offer high quality biosimilars understanding patients’ needs,” he added.

Biosimilars differ from generics in that they are close copies of, rather than identical to, off-patent biologic brands.

Growing interest in biosimilars

+ Boehringer’s move mirrors that of Merck & Co, which entered the sector in earnest in 2009 after creating a dedicated division, Merck BioVentures, and has shown serious intent this year in particular.

+ In June Merck announced it was to develop its own version of Pfizer’s ageing arthritis drug Enbrel with South Korean manufacturer Hanwha Chemical Corporation.
Hanwha has been working on HD203, a candidate biosimilar form of TNF inhibitor Enbrel (etanercept).

+ And in January Merck entered an agreement with contract research organisation Parexel to help boost biosimilar development: the company has said it planned to have five biosimilars in late-stage clinical trials by 2012.

+ Those in the pipeline include a biosimilar of Amgen’s Neupogen (filgrastim), an investigational recombinant granulocyte-colony stimulating factor (G-CSF) drug to prevent infections in cancer patients receiving chemotherapy.

Pharma manufacturers are not the only ones showing an interest in biosimilars: earlier this year South Korean electronics giant Samsung formed a joint venture with Quintiles to break into the market. At the heart of the tie-up is the construction of a biopharmaceutical production facility in Songdo, South Korea, with the intention of getting its first biosimilars to market in 2016.

Adam Hill

Tech opportunity in biologics - biosimilar drug market

Biosimilar is a hot issue these days among bio-pharmaceutical businesses. Well, today no one could predict the future and tell a definite answer whether the biz idea could indeed be realized (as those investors has wanted). However, I could see there are number of opportunities for chemical engineers if the biosimilar business is indeed accepted by common and politicians. The opportunities would present in bio-pharmaceuticals, including (1) downstream process modeling (2) continuous processes, especially in reaction and purification (3) biosimilar properties, and may be more. Since the bio-species are large molecules and its physical properties are mostly not known, therefore it is likely that a computer simulation approach upon molecular modeling and statistical physics could get attention from publics and eventually any predictive methods should be incorporated with first principle mathematical models in chemical engineering. Such demand may be challenging for those who has fixed idea in traditional chemical engineering approach, but it would create big opportunities for those who has young and new mind with ability to integrate IT and chemical engineering….

Here is a news about Samsung’s involvement in biosimilar business. Such movement indicate it is not a joke.. Samsung won’t do this if it is not feasible idea. They are good and smart. (Original article posted at http://www.firstwordplus.com/Fws.do?articleid=1003E8EAB47E4ECDA43229969E719985)

Samsung announced plans to establish a joint manufacturing venture with Quintiles to produce biologic drugs, as part of a series of moves by the South Korean company to diversify its businesses in order to drive growth. Samsung executive vice president Kim Tae Han noted that the unit is expected to start supplying biologic drugs in the first half of 2013, adding that the company is also looking to enter the biosimilar market.

The joint venture, which will initially have 300-billion won ($266 million) of capital, will begin construction of a plant near Seoul in the first half of the year. Once operational, the facility will produce biologic drugs under contract, with the majority being sold overseas. Kim remarked that due to demand for biopharmaceuticals, Samsung may exceed its target to generate 1.8 trillion won ($1.6 billion) a year by 2020 from these products.

Kim added that the company may also establish another joint venture to make biosimilars this year. In May, Samsung said it had 23.3 trillion won ($20.7 billion) to invest in five new business areas by 2020, with 2.1 trillion won ($1.9 billion) set aside for biopharmaceuticals. Half of the budget for biologic drugs will be spent on developing the products and the other half will be used to construct factories.

The executive said the first biosimilar that Samsung would target would be Roche and Biogen Idec's Rituxan (rituximab), which has patent protection in the US until 2018 and in the rest of the world through 2013. The company expects to begin producing biosimilars in 2016, and ultimately aims to develop its own biopharmaceuticals after gaining experience in making them, Kim commented.

Column dynamics for non-Langmuirian equilibrium

We often see quite complex column dynamics when equilibrium does not follow a Langmuir type (i.e. IUPAC Type I). As a matter of fact, the effects of the equilibrium isotherm shape on breakthrough curve or chromatogram are far more significant in process design, revamp and analysis. I found this interesting video does demonstrate such interesting dynamics in liquid chromatography column.

Another one for VARICOL process

Very interesting SMB simulator in YouTube