The European Medicines Agency ("EMEA") made its
biosimilar monoclonal antibody guidelines effective in December
20121. Less than a year later, in September 2013, it
approved Europe's first biosimilar antibody. The drug is
Inflectra which is a biosimilar of Remicade (infliximab), an
anti-TNF-α antibody to treat autoimmune diseases, such as
rheumatoid arthritis. Remicade sales in Europe were over US$2
billion in 2012. The innovator product was developed by Centocor
(now Janssen). The biosimilar was developed by South Korean company
Celltrion and has been on sale in the company's home market
since 2012 under the brand Remsima. Hospira is a marketing partner
of Celltrion in Europe and North America and will sell under the
Inflectra was approved in Europe for the treatment of
inflammatory conditions including rheumatoid arthritis, Crohn's
disease, ulcerative colitis and psoriasis. The EMEA was willing to
fully extrapolate from the clinical data set in the drug submission
to the other approved previously approved indications for the
Hospira appears free to launch the product in some European
countries, but in several major European countries the launch is
blocked by Janssen patents until at least February 2015.
Celltrion and Hospira have stated that they will eventually be
seeking approval of their infliximab biosimilar in the U.S. Janssen
blocking patents on infliximab are in effect in the U.S. until at
least 2015. Industry observers will be very interested to see how
the FDA regulates the biosimilar of a complex protein antibody
reference product (assuming that the biosimilar is ultimately
approved). For example, the issue of extent of extrapolation of
indications could potentially be assessed differently by the FDA
than the EMEA. There may also be an issue whether biosimilar
may use the infliximab name (the same international non-proprietary
name (INN) as the reference product), or whether it will have to
use a modified name.
Celltrion received marketing authorization for infliximab in
Canada in January 2014 (brand names Remsima and Inflectra). It was
reported that Canada did not extrapolate data in biosimilar new
drug submission to all the approved indications2. The
reasons for this limitation were not yet published by Health
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
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