Biosimilars – a case of more for ledderhose disease radiotherapy less the petri dish

CONTRARY to popular opinion, biologics, a large molecule typically derived from living cells and used ledderhose disease radiotherapy in the treatment, diagnosis, or prevention of disease, have been around for a long time and regulations overseeing ledderhose disease radiotherapy biologics can be traced back to the Biologics Control Act, 1902 in the United States of America (also known as the Virus-Toxin Law).

The regulations for biologics now include the regulation of vaccines, blood and blood components, allergenic patch tests and extracts, human immunodeficiency virus (HIV) and hepatitis tests, gene therapy products, cells and tissues for transplantation, Insulin, protein therapeutics, antibodies and new treatments for the treatment of cancers and ledderhose disease radiotherapy other serious diseases.

Biosimilars are biological products that are almost an exact copy ledderhose disease radiotherapy of an original product that is manufactured by another company ledderhose disease radiotherapy and approved by the relevant Pharmaceutical Regulatory Body. In the case of Malaysia, the competent regulatory body would be the National Pharmaceutical Regulatory ledderhose disease radiotherapy Agency (NPRA) under the aegis of the Malaysian Ministry of Health.

“We have been involved in trying to bring biosimilars into ledderhose disease radiotherapy Malaysia for over seven years and have witnessed, first hand, the strategies adopted by Innovators to either extend patents on ledderhose disease radiotherapy products that have gone off patent globally or alternatively to ledderhose disease radiotherapy retain monopolies on supply of these products by utilising predatory ledderhose disease radiotherapy pricing to stop development of biosimilars,” said Leonard Ariff Abdul Shatar, Group Managing Director of Duopharma Biotech.

Before Biocon announced its intention to set up a human ledderhose disease radiotherapy insulin facility in Malaysia in 2010, human insulin was priced at RM42/box in the government sector and RM104/box in the private sector. Biocon, through Duopharma Biotech, was awarded a three-year contract to supply human insulin in late 2016 at ledderhose disease radiotherapy a price that was 24% cheaper than the prices back in 2011 even though the ledderhose disease radiotherapy Malaysian ringgit has depreciated markedly during the period. This represented a RM32 million savings to the government per ledderhose disease radiotherapy year.

“Before Duopharma Biotech announced its development of biosimilar EPO in ledderhose disease radiotherapy 2011, EPO supply to the government was RM25/dose. During the latest Government tender submission, Duopharma Biotech’s biosimilar EPO submission price was a drop of over ledderhose disease radiotherapy 40% compared to the prices in 2011. This represents another RM9 million savings to the Malaysian Government.

“We saw this clearly when the Innovator overnight dropped the ledderhose disease radiotherapy price of Trastuzumab by 52% in a recent government tender and was still awarded the ledderhose disease radiotherapy tender even though the biosimilar had quoted a 50% drop in price. To put this into perspective, for the same volume of Trastuzumab, the contract price is now RM21 million over two years ledderhose disease radiotherapy relative to RM43 million under the previous contract price before ledderhose disease radiotherapy the introduction of the biosimilars.”

“Policy ambivalence towards the predatory pricing we are witnessing today ledderhose disease radiotherapy in the biologics space, either by way of dropping prices to stop competitors registering ledderhose disease radiotherapy biosimilars or drastically dropping prices once a biosimilar has achieved ledderhose disease radiotherapy registration, will only provide short term gains at the expense of ledderhose disease radiotherapy creating a more competitive environment,” said Leonard.

Malaysia definitely has the unique opportunity to create a competitive ledderhose disease radiotherapy biologics landscape to improve accessibility of these treatments to patients ledderhose disease radiotherapy who would not have ordinarily been able to afford these ledderhose disease radiotherapy treatments. Some countries in Europe, where Biosimilars have been growing at a very fast pace, have even gone so far as to allow for interchangeability ledderhose disease radiotherapy of Biosimilars with Innovator products.

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