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Clearing US biosimilar pathway hurdles is expected to be an arduous exercise
Biosimilar development is riddled with complexities, ranging from regulatory, to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry.
On March 23, 2010, Presiden...
HIRAS selects 10 BPH based subjects
The Health Insurance Review Assessment and Service said on April 15 that it will evaluate the following ten healthcare subjects, such as therapeutic interventions, diagnostic test and medicinal products, based on the ...
Choong-wae opens biggest cGMP plant
Choong-wae Pharm will start operation of a state-of-art cGMP plant from August in Dangjin of South Chungcheong Province that will produce a total of 1.5 billion drugs, including 130 million liquid forms, 1.35 billion ...
Bioequivalence testing to be made compulsory for capecitabine generics
Local drug manufacturers who intend to obtain the product license for a generic version of capecitabine will be required to conduct bioequivalence testing instead of comparative dissolution test, according to the Kore...
Bracco Imaging sets up Korean unit
Italy based Bracco Imaging, a worldwide provider of diagnostic imaging solutions, said it has established its Korean unit Bracco Imaging Korea.
The Korean unit will market X-Ray Imaging (conventional X-Ray and Comp...
KFDA to evaluate risk of cardiovascular events with sibutramine
The Korea Food and Drug Administration says it is reviewing final data from a recent study (SCOUT) suggesting that patients using sibutramine have a higher number of cardiovascular events than patients receiving place...
KFDA advocates vaccine authority
When the influenza A (H1N1) fear swept the world last year, Koreans were relieved over the domestic availability of vaccines. Green Cross Corporation produced the vaccine "Green Flu S" in December.
The Korea Food ...
Careful approaches needed over two-way sanctions
The government has submitted a relevant bill to the National Assembly to establish the legal grounds to suspend the licenses of doctors who take the money for up to one year.
Under the new rules, doctors, pharmaci...
KPMA to comply with complaints of small package system
The Korea Pharmaceutical Manufacturer Association said it will extend the period of its test-run system to deal with any complaints associated with small drug package system in a bid to make it “better” for both manuf...
Non-members of KPMA urged to abide by new fair trade code
Pharmaceutical companies which do not belong to the Korea Pharmaceutical Manufacturers Association will also have to undergo an association review when donating to hospitals under the new detailed standards defining r...
