13.04.2012

Biosimilar Remicade Accepted for EU Drug Review

Europe's drugs watchdog is to evaluate a copycat version of the best-selling biotech drug Remicade, used to treat arthritis, in a move that underscores how the market for so-called biosimilars is opening up. The European Medicines Agency's latest list of validated new drug applications includes one for a biosimilar version of infliximab, the generic name for Johnson & Johnson and Merck & Co's Remicade. more24.01.2012

EU Agency Issues Guideline on Biosimilar MS Drugs

European regulators took another step towards opening the market for copies of biotech drugs on by releasing a draft guideline on how companies should test biosimilar medicines containing interferon beta, used to treat multiple sclerosis. The guideline is open for consultation until the end of May 2012 and is part of a package of new regulations being prepared by the London-based agency. more31.10.2011

Lonza Sees Growth on Pharma Outsourcing

Swiss drugs industry supplier Lonza is set to grow underlying sales and operating profit this year despite the strong Swiss franc as it benefits from robust demand from pharmaceutical groups, particularly at a plant in China. more28.10.2011

Peter Pollak on the World of Fine Chemicals

In his book "Fine Chemicals - The Industry and the Business," Dr. Peter Pollak provides a comprehensive view on one of the most challenging segments of the modern chemical industry, and a practical guide for succeeding in the multibillion dollar fine chemicals business.
more14.06.2011

The World Of Biosimilars

Doubled-Edged Sword - The emergence of biosimilars has caused very large ripples in the biopharma pond, and has recently been called the most "disruptive technology" of the decade. True to a point, but dynamic change for some is usually accompanied by significant opportunity for others. This is the "double-edged sword" paradox of the biosimilars market.

In simple terms, biosimilars are the biotech industry's version of chemical generics. more29.03.2011

Biosimilars Seen as a $3.7 billion Drug Market by 2015

The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as a raft of branded drugs lose patent cover, according to market analysis firm Datamonitor. Many drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as regulators draft new rules for their approval. more18.02.2011

Biosimilar Monoclonals: Rising Above the Challenges

Embracing Monoclonals - Modern manufacturing methods and analytical tools have developed to a level that enables assured production of highly similar monoclonal antibodies. In Europe, the biosimilar revolution has begun to embrace monoclonals, and to date, the Committee for Medicinal Products for Human Use (CHMP) has provided scientific advice on the development of a number of biosimilar monoclonals, and draft guidelines are imminent. more10.02.2011

Sandoz Has 10 Biosimilars in Pipeline

Novartis´ generics unit Sandoz is working on eight to 10 new biosimilar molecules to cement its position as leading maker of copycat versions of pricey biotech drugs, the unit's head told Handelsblatt. The drug candidates are in varying stages of development, the head of Sandoz, Jeff George, was quoted as saying in the German paper's Wednesday edition. more27.01.2011

Lonza Expects Solid Growth in 2011, 2010 Net Up 79%

Swiss drugs industry supplier Lonza said on Wednesday it expects solid growth in 2011 after meeting forecasts with a 79 percent rise in full-year net profit. Net profit at the group rose to 284 million Swiss francs ($299.9 million) as better capacity utilization helped offset the negative impact of the strong Swiss franc and high raw material prices. "Lonza's increased financial flexibility will open up expansion opportunities in our life-science-focused value chain," the Basel-based group said in a statement. more11.01.2011

Novartis Starts Phase II Trial for Copy of Roche's Rituxan

Novartis advanced its bid to copies Roche's multi-billion dollar antibody drug rituximab on Monday, starting phase II trials for its own version of the blockbuster medicine. Drugs firms are racing to come up with versions of Roche's drug Rituxan, which raked in 6.1 billion Swiss francs ($6.33 billion) for it in 2009. Known as MabThera in Europe, it is used to treat non-Hodgkin's lymphoma (NHL) and rheumatoid arthritis. more