These glycan species are not resolved in
Enbrel samples in our routine HPLC method or the UPLC method.
Pfizer's
Enbrel is a recombinant human TNF-alpha receptor fusion protein that inhibits the activity of TNF-alpha.
Approval for all of
Enbrel's indications--plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, anky-losing spondylitis, and polyarticular juvenile idiopathic arthritis--was initially met with skepticism by members of the agency's Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against
Enbrel in patients with plaque psoriasis only.
Although TB risk has been observed following treatment with all anti-TNFs, the warning mentions that "data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with
Enbrel (etanercept) than with TNF-blocking monoclonal antibodies."
"The partnership between Wyeth and Takeda to co-promote
Enbrel should help make Japan one of the strongest markets for this important biotech product," says Bernard Poussot, President, Wyeth Pharmaceuticals.
Remicade and
Enbrel work by switching off tumour necrosis factor (TNF), a chemical that stimulates cells to produce the inflammation response.
Only 30 Welsh patients have received
Enbrel, which was licensed last year.
Piper Jaffray analyst Christopher Raymond reiterates an Overweight rating and a $210 price target on Amgen's (AMGN) shares following news that the company has won the
Enbrel IP litigation with challenger Sandoz.
Comments:
Enbrel sales were down 13% to $1.4 billion due to lower unit demand and net selling price.
Bioepis specialises in the development of biosimilars for drugs such as Johnson & Johnson's (NYSE: JNJ) Remicade and Amgen's (NASDAQ: AMGN)
Enbrel, which are blockbuster rheumatoid arthritis drugs.
Erelzi is a biosimilar to
Enbrel (etanercept), which was originally licensed in 1998.
regulatory pipeline are inhibitors of tumor necrosis factor-alpha, not surprising as these biosimilars correspond to brand drugs that are both reaching the end of their patent protection--Remicade (infliximab), Humira (adalimumab), and
Enbrel (etanercept)--and also have high levels of U.S.
*
Enbrel (etanercept; Pfizer): Could
Enbrel benefit from pushing its risk profile more to physicians?
Amgen's revenue will drop as much as 4% to $14.4 billion this year on depressed demand for the arthritis drug
Enbrel and the anemia therapies, Aranesp and Epogen, the company said on April 23.
