Farmaci Biologici

Stanno per arrivare nei prossimi anni farmaci cosiddetti Biologici, (o ingegnerizzati) perche' derivano da anticorpi umani o animali a cui viene inserita la parte di attacco con uno specifico sito di legame.
Giusto per fare un esempio e' un po' quello che avviene tra la chiave e la serratura, se la chiave non e' la sua la serratura non sia prira' mai.
Per altra patologie, Es Artrite reumatoide, o tumori sono gia presenti, ma stanno per arrivare anche per combattere l'hiv.
In genere si iniettano sottocute o si infondono con una flebo, in quanto si tratta di materiale soggetto a rapido deperimento.

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Next generation biologic drugs provide hope for HIV/AIDS patients
By James Sykes - 01/26/11 02:57 PM ET

Our nation’s political capital, Washington D.C. also has the notorious distinction of being the HIV and AIDS capital of the United States, with at least 3 percent of its residents infected. This rate is higher than most countries in West Africa and exceeds the 1% cut-off that marks the U.S. Centers for Disease Control and Prevention’s definition of a generalized epidemic. Many patients with this disease also suffer from complications like kidney failure and anemia. New high-tech therapies for treatment of HIV/AIDs, however, have turned what was once a terminal illness into a potentially chronic, manageable condition.

Since 1987, we have witnessed the transformation of HIV/AIDS care and treatment from one drug (AZT) to over 31 drugs. Patients no longer need a cocktail of 15 pills per day in their daily regimen to function – they can now function on just a few. Given this rate of innovation, The AIDS Institute, along with other community partners, has supported legislation that would promote the flow of innovative drugs for the treatment of HIV/AIDS and other diseases and conditions. This includes support for biologic medicines, which are the new frontier for long-term management of HIV/AIDS.

Biologics present a world of possibilities beyond pharmaceuticals. Instead of being synthesized using chemical reactions, biologics are derived from human or animal proteins. They are engineered to support the body’s natural immune system to treat, prevent, or cure illnesses. Currently there are biologics already being used to effectively treat HIV-related anemia as well as anemia related to kidney failure and chemotherapy. Insulin and vaccines are also long-established examples of biologic products. Biologics are unique because they are made from living organisms that are immunogenic and thereby able to elicit an immune response. They are far more complex than most drugs which are chemically synthesized, and whose structures are therefore known. As no two biologic drugs are the same, small differences in the composition of these drugs can have unexpected consequences on the body. As promising as biologics are, patient safety must be paramount.

Patient safety should also guide the FDA in its current implementation of a biosimilars pathway to enable biosimilar versions of these drugs to enter the U.S. market. The FDA should set out clear and robust comparative testing requirements, considering the current state of the science, to demonstrate safety and efficacy. We also think that given the fact that no two biological products made by different manufacturers are identical, biosimilars must not be treated like traditional generic drugs. And once a biosimilar is proven to be safe and effective through rigorous clinical testing, there must be safeguards in place to help healthcare providers avoid inappropriate drug substation without physician knowledge and approval. Lastly, we think that biosimilars should have unique names, or at a minimum – barcodes – to differentiate products. This will help the FDA track any drugs responsible for adverse events and avoid unnecessary confusion.

These requirements to ensure the safety of biologics and biosimilars have been the standard in the European Union and Canada, amongst other jurisdictions and should be adopted by the United States. Given the prevalence of HIV/AIDS rates in our federal government’s backyard, there is no time more pressing than now to support drug innovations that save lives and reduce patient suffering. While the ultimate goal is to provide quality health care for those who cannot afford it, we believe the best way forward for regulating biosimilars is with a thoughtful, open and transparent process that considers the current state of science and ensures patient safety.

James Sykes, MPH, is the Director of Global Policy at The AIDS Institute.


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