the present treatment goals for inflammatory bowel diseases (ibd) especially ulcerative colitis (uc) include rapid induction of clinical remission, steroid-free maintenance of clinical remission, mucosal healing and improvement of quality of life in uc patients. immunomodulators have been reserved for steroid- dependent or steroid- refractory uc patients. among these agents, azathioprine/6-merc...

*Vice President Manufacturing Science and Technology, Cytovance Biologics, Inc., Oklahoma City, Oklahoma, **Senior Vice President Operations, Cytovance Biologics Inc., Oklahoma City, Oklahoma, ***Vice President Quality Systems, Cytovance Biologics Inc., Oklahoma City, Oklahoma, †Senior Vice President Regulatory Affairs, Cytovance Biologics Inc., Oklahoma City, Oklahoma, ††Executive Director Qua...

With spending on biologics rising and patent expiry approaching for several blockbuster biologics, Congress and the Food and Drug Administration are considering creating a clear pathway for so-called follow-on biologics. Differences between drugs and biologics will affect market outcomes in various ways. Conservative budget impacts are appropriate in the short run because fewer competitors will...

Biologics (biomolecule drugs) play a key role in modem medicine, yet assuring their quality and safety remains a major challenge for the biopharmaceutical industry. Developing a platform for rapid and reliable assessment of biologics activity is critical for quality control of biologics manufacturing and safety assurance. Herein we introduce a generally applicable platform for this purpose, usi...

Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologics are manufactured through fermentation, a process that is more variable and costly. Re...

The patent expiration for first-generation biological drugs has prompted the development of a new group of biopharmaceuticals - follow-on biologics. The extent of studies needed in the process of follow-on biologics approval is incomparably greater than in the case of generics but reduced in comparison to innovative biologics. The basis for the approval is to show the similarity sufficient to e...

Biologics are the most successful drugs used in anticytokine therapy. However, they remain partially unsuccessful because of the elevated cost of their synthesis and purification. Development of novel biologics has also been hampered by the high cost. Biologics are made of protein components; thus, theoretically, they can be produced in vivo. Here we tried to invent a novel strategy to allow th...

Introduction Treatments of severe rheumatic conditions in children are increasingly based on biologics. The most common adverse events on all kind of biologics are mild infections in ENT, pulmonary and urinary systems. The number of cases of varicella-zoster-virus (VZV) manifestations while being on biologics is constantly growing. No consensus exists about what to do when facing this situation...

Patients with inflammatory diseases are treated with a variety of biologic agents. The association between use of biologics and tuberculosis is well known. Additionally, there are numerous case reports of infections in patients receiving biologics with organisms such as Pneumocystis, Listeria, Legionella, and Salmonella. Data from the US Food and Drug Administration Adverse Event Reporting Syst...