Month: July 2014
The industry’s 10 biggest-selling cancer drugs generated combined sales of $37.4billion in 2013, with Roche’s Rituxan, Avastin and Herceptin franchises extending their lead at the top of this league table. With combined sales of around $21 billion, these three drugs alone accounted for approximately 56 percent of the combined value of the 10 biggest-selling products.
|Velcade||Johnson & Johnson, Takeda,Pharmstandard|
|Erbitux||Merck KGaA, Bristol-Myers Squibb|
|Lupron, Eligard||AbbVie and Takeda; Sanofi and Astellas Pharma|
|Zytiga||Johnson & Johnson|
Rituxan is developed by Roche’s Genentech which is the first monoclonal antibody treatment for cancer. And even after 15 years on the market, it continues to see its sales grow, up 6% for Roche in 2013. The drug is also approved to treat a number of cancers, including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (CLL), it also works against rheumatoid arthritis and generates about $1.2 billion a year in that category.
By comparing the sales of all the drugs the Roche company becomes the king of all the Pharmaceutical Companies involved in making oncology drugs.
Let’s have a look over the ranking on the basis of oncology sales 2013.
Roche has topped the ranking by its top selling drugs, followed by Amgen, Novartis, Celgene, Johnson and Johnson, Lily, Astrazeneca, Merck, BMS and Takeda.
Compare the global sales of 2013 and 2012 of the top ten blockbuster drugs which is losing patent this year. Teva Pharmaceutical’s Copaxone is the most affected drugs in terms of sales as the sales of 2013 has increased to 4.328 billions bearing the highest loss. Least affected Drug is AbbVie’s Trilipix which has faced the decrease in sales from 1.098 billions to 303 millions.
Table: Global Sales of Blockbuster Drugs for 2012 and 2013
|Brand Name||Global Sales 2012 USD (b)||Global Sales 2013
On May 30, 2014, the U.S. Food and Drug Administration approved the first generic versions of Celebrex (celecoxib) capsules. Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.
Celebrex is a Pfizer’s blockbuster anti-inflammatory drug. Global sales of Celebrex exceeded USD2.1 billion, in the first nine months of 2013 which was a 13 percent increase on the same period the previous year.
Patent protection from US16059493A originally expiring in November 2013 in the US, paediatric extensions have extended the expiry of the molecule and composition patents, US 5,466,823 (‘823) and US 5,563,165 (‘165), a further six months, until May 2014. This was the primary hurdle for the companies wishing to develop generic equivalents.
Celecoxib is a selective COX-2 sulphonamide non-steroidal anti-inflammatory drug (NSAID), marketed by Pfizer, Pharmacia and G.D. Searle (both subsidiaries of Pfizer) under brand name Celebrex, Celebra for arthritis and Onsenal for polyps. It is indicated for use in the treatment of osteoarthritis, rheumatoid arthritis in patients 2 years or older, ankylosing spondylitis, acute pain and primary dysmenorrheal.
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.
On 27 June 2014, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) had recommended granting of marketing authorization for a biosimilar insulin glargine product (LY2963016).
Eli Lilly and its partner Boehringer Ingelheim has produced the biosimilar insulin glargine, which will be called as Abasria (LY2963016). The drug is a biosimilar of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).
To date, EMA has approved 21 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoietin, insulin and TNF-inhibitor, for use in the EU.
Two biosimilar approvals have been withdrawn; one for filgrastim in April 2011 and one for somatropin in May 2012, leaving a total of 19 biosimilars approved for use in Europe.
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