Biologics like Amgen's Enbrel--a protein drug for immune diseases including rheumatoid arthritis and psoriasis--have become blockbusters.
Biologics now account for half the products currently in Phase II and Phase III clinical trials.
Pharmas are also continuing their strategic embrace of biologics, a move driven by two key considerations.
First, most biologics target serious conditions, for which a high level of reimbursement is expected.
But since the birth of biotechnology 30 years ago, biologics has come into its own.
The acquisition targets share two traits: steep selling prices and a focus on protein-based drugs, called biologics.
It is extremely likely that the CATT trial will show no difference in efficacy between the two biologics.
Macrocycles offer a number of advantages over bigger biologics, including better ligand efficiency, tissue penetration, delivery, and cost.
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Lilly could make a play for Biogen Idec, whose expertise in biologics for neurology and cancer would fit well.
One high-impact provision being debated is 12 years of data exclusivity protection for biologics, complex medicines that treat debilitating chronic diseases.
Many of the knockoffs will be classified as comparable to branded biologics, but not copies that a pharmacist could automatically substitute.
What can't be legislated away is the high cost of producing biologics.
RichardClarkRichard Clark, Merck's chief executive, says, "We believe we can be the leaders" in the follow-on biologics field based on the GlycoFi technology.
Richard Clark , Merck's chief executive, says, "We believe we can be the leaders" in the follow-on biologics field based on the GlycoFi technology.
The GPA noted in its commentary on the New York Times article that many companies who are developing biosimilar products also manufacture branded biologics.
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Therefore, as the name implies, all new generic biological drugs, also called "biosimilars" or "follow-on biologics, " will be similar--but not identical--to the original drugs.
Firms now in human trials of this approach include Dendreon of Seattle, Cell Genesys in South San Francisco, England's Onyvax and Therion Biologics near Boston.
For one thing, the most advanced candidates in the pipeline are biologics, compounds that are not administered orally but instead by injection twice a month.
Its billions of dollars that payers are putting out for biologics.
Biologics are large molecules, often with tens of thousand of atoms.
Ultimately, it will be the archival system of record for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) as well.
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Biologics like Amgen's (nasdaq: AMGN - news - people ) Enbrel--a protein drug for immune diseases including rheumatoid arthritis and psoriasis--have become blockbusters.
The new manufacturing plant will be complementary to Angel's existing core business in advanced biologics, which includes biopharmaceutical proteins and cell therapies, such as stem cells.
Consequently, they have expressed their intention to submit a new Biologics License Application (BLA) to obtain marketing approval, rather than an abbreviated submission via the biosimilars pathway.
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Second, biologics are really difficult to copy, and thus even after the patents expire, knock-off biologics (biosimilars) are far less a threat than knock-off small molecules (generics).
Macrocyclic drugs are an emerging class of therapeutics that promise to open up drug target spaces which are poorly addressed by small chemical entities and larger biologics.
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Pfizer's acquisition of Rinat Neuroscience of South San Francisco, announced last month, takes the world's largest pharma company a step further into the world of biologics as well.
In the case of a newer drug class called biologics, the cost could be even higher, as they are highly complex large-molecule medicines that cannot be easily produced.
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Now clearly with drug companies we have to do more to get generic drugs to market, including the new biologics that are coming into the marketplace and are often extremely expensive.
Manufacturers will have to get doctors to overcome their comfort and experience with using branded biologics and persuade them to prescribe something comparable, said Gillian Woollett, a biosimilars expert at consulting firm Avalere Health.
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