Biosimilars or Generics? A Question of Morality Marketing Articles | June 22 Theo Walcott Jersey , 2015 Pharmaceuticals have always been under the lens with regards to morality. The prime accusation is of considering pharmaceutical or drug industry as a profit oriented business. Conducting simultaneous ...
Pharmaceuticals have always been under the lens with regards to morality. The prime accusation is of considering pharmaceutical or drug industry as a profit oriented business. Conducting simultaneous clinical trials of safety and efficacy, limiting the clinical trials period from the standard and marketing the drug even after failing the safety standards are few blunders done by pharmaceuticals just to have first mover advantages to out beat the competitor.
The subject of concern is, is it about profits and winning or care and safety? Now a days, a strong new wave of ''biosimilars'' is encroaching the shore of pharmaceutical offerings. Biosimilars or 'follow-on' biologics are biological products that are similar, but not identical Shkodran Mustafi Jersey , to an innovator product that is already marketed and whose patent has typically expired. Whereas, generics are identical and equivalent to the innovator product.
When it comes to approvals, the biosimilars get quick ''clean chit'' just after cross checking the clinical records with that of reference or parent product. But in the case of generics, they have to cover longer paths and pass every hurdle of clinical trials and emerge spot less. Hence, it can be said that it is easy to get approval for biosimilars than the generic drugs.
Now let's put light on the efficiency and effectiveness of both. A major concern with biosimilar drugs is immunogenicity. As these products are often manufactured in living cells (for example hamster Sead Kolasinac Jersey , rabbit or bacterial cells), they are considered foreign by the human body and induce immune responses such as neutralizing antibodies. Immunogenicity can be affected by various factors including manufacturing processes and impurities. Impurities may derive from chemicals or antibiotics used during production or from microbial or viral contamination. These can compromise the purity of the final protein and may alter its structure or properties. Generics on the other hand show slight to no variation in regards to effectiveness and are quite accurate in their results.
Analytical tests can characterise molecular mass, protein content, glycosylation pattern, in vitro activity Santi Cazorla Jersey , physicochemical integrity, stability, impurities and additives of a biosimilar product. However, these analyses will not guarantee equivalent efficacy and safety to the innovator drug in the relevant patient population.
This brings to the fore, biosimilars have tendencies to induce a adverse immune response and at times may not even give desired cure result because of the alteration caused by them on the antibodies. Then why not to stick to the generic identical version of original drug which gives desired results than going for biosimilars?
The Global market for Biosimilars is expected to reach $28 Rob Holding Jersey ,200 million by the end of 2020 growing at a CAGR of around 40%
The key advantage of biosimilars is that they cost 20-25% less than the originator product due to reduced clinical trials
Many established players are trying their best to capitalize on this trend and fetch at most possible benefits.
Article Tags: Clinical Trials
Be careful when following the crazy yellow brick link trail. Computers Articles | October 23, 2004 Links, what are they? When you go to a web site, links are the little bits of ... that when clicked on will take you to another website of similar context. The thing is, with these strange and
Links Petr Cech Jersey , what are they? When you go to a web site, links are the little bits of information that when clicked on will take you to another website of similar context. The thing is, with these strange and mysterious human minds of ours that we know so little about, these links if navigated subconsciously can take one to places of information you normally would never travel to. You could start out in the light and end up in a black hole. Let me give you an example of a trail I recently traveled without really thinking.
The other day I decided to search for a web site about one of my all time favorite musicians, Arlo Guthrie. Arlo Guthrie is a folk musician Per Mertesacker Jersey , son of another famous musician Woody Guthrie. When I was a little kid, one of the coolest things to do was to listen to his storysong entitled ?The Motorcycle Song?. So, I found his personal website through a Google search and it was pretty cool, and very positive. Guthrie runs a charity organization and a multi-religious church center where money is raised to help people with illnesses as well as giving less fortunate people a place to pray, meditate or just get off the streets.
So Olivier Giroud Jersey , I?m reading all about Arlo in his biography and there?s a link to his court statement at the famous Chicago Seven court case. Well, as I?m a young guy I had never heard of this case, my curiosity was piqued and I clicked on the link. Next I was reading Arlo?s funny comments about the time he was arrested for disposing of garbage in an illegal area on Thanksgiving because the dump was closed. Of course if you know about Guthrie you?d know that his famous song ?Alice?s Restaurant? was based on this story. I get to the finish of the court transcript and there?s a link for the ?Famous Trials? web site that the Chicago Seven trial was a page of.