China
Africa
Explore chapters and articles related to this topic
Advances in Wet Granulation of Modern Drugs
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Bing Xun Tan, Wen Chin Foo, Keat Theng Chow, Rajeev Gokhale
The pharmaceutical industry is witnessing a paradigm shift from traditional small-molecule drugs to biological therapeutics. In 2016, 9 out of the top 10 global best-selling pharmaceutical products were biologics [52]. Biologics are therapeutic large molecules produced from biological sources and cover a broad range of products including recombinant proteins and their associated derivatives, vaccines, as well as cell-based and gene therapies. Of these, therapeutic proteins such as monoclonal antibodies represent the most successful and commercialized category. The structural complexity of therapeutic proteins confer the advantages of high potency and specificity; however, its inherent lability presents formulation and bioavailability challenges to biopharmaceutical scientists.
Introduction to dermatological treatment
Published in Richard Ashton, Barbara Leppard, Differential Diagnosis in Dermatology, 2021
Richard Ashton, Barbara Leppard
Biologics are antibodies that target specific cells, mediators or molecules (see Table 2.02). Their number and uses are expanding rapidly. They are very useful in patients with extensive psoriasis, atopic eczema and chronic idiopathic urticaria unresponsive to immune-suppressives, and seem to have a good side effect profile, not affecting either the liver or kidneys. All these drugs may lose efficacy over time probably due to the development of antibodies or decreased bioavailability, but dose frequency adjustment or switching between classes will help to overcome any loss of efficacy. It is recommended to have the relevant immunisations up to date prior to commencing a biologic. Seasonal flu and pneumococcal vaccinations are recommended. Live vaccines should be administered 4 weeks before starting a biologic or 6 months after discontinuing it. They are all extremely expensive (biosimilar anti-TNFs cost £2000/year, while the interleukin inhibitors cost around £8000/year).
Little Pharma and Friends
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray
Specialty Drugs are used in a variety of conditions – alcohol/opiod dependence, cancers, anemia, and even as a contraceptive intrauterine device (Kyleena, above). In 2018, Bristol-Myers Squibb boasted the top two sellers in dollar volume, followed by a Pfizer product, and then one by Johnson and Johnson. Such sales are in the billions. These biologics are often given by infusion or injection, thus requiring quick distribution and special skills in handling at the delivery site. The FDA, recognizing the special characteristics of this class of biologicals, has issued “Risk Evaluation and Mitigation Strategies” (REMS) to help insure that the benefits of use outweigh the risks. [Author’s Note: Only a Government Agency could come up with such an obfuscating title. With this as a model, I have now named the little lean-to where I keep my lawnmower: The Carport Storage Facility (CSF)].
Cost-efficiency analysis of conversion to biosimilar filgrastim for supportive cancer care and resultant expanded access analysis to supportive care and early-stage HER2+ breast cancer treatment in Saudi Arabia: simulation study
Published in Journal of Medical Economics, 2023
Consuela Cheriece Yousef, Mansoor Ahmed Khan, Hind Almodaimegh, Majed Alshamrani, Meteb Al-Foheidi, Hana AlAbdalkarim, Ahmed AlJedai, Anjum Naeem, Ivo Abraham
Biologics are large molecules manufactured in genetically modified living cells or organisms and are used to diagnose, treat, or prevent disease.1,2 With patents of many of the biologics expiring, biosimilars – that is, biologics that are highly similar to a licensed reference product – have become available and provide an opportunity to reduce pharmaceutical spending and increase access to treatment while offering comparable efficacy and safety.3,4 Biosimilar approvals are based on equivalence studies relative to a reference biologic product in terms of physicochemical properties and clinical evidence.5 In 2005 the European Union implemented a legal framework and regulatory approval pathway for biosimilars, and the first biosimilar, human growth hormone, was approved in 2006, followed by epoetin alfa in 2007 and filgrastim in 2008.3,6,7 In 2012, the United States Food and Drug Administration issued guidance on biosimilar approval requirements, with the first biosimilar, filgrastim-sndz, approved in March 2015.8 Although initially the uptake of biosimilars was slow, they are now commonly used in Europe and increasingly in the US. Other countries, such as the Kingdom of Saudi Arabia (KSA), have more limited experience with biosimilars. Biosimilar guidelines were developed in 2010, while the first filgrastim biosimilar (Zarzio) was approved in 2014.3,9
Incremental net monetary benefit of biologic therapies in moderate to severe asthma: a systematic review and meta-analysis of economic evaluation studies
Published in Journal of Asthma, 2023
Sajesh K. Veettil, Vanessa Vincent, Taylor Shufelt, Emma Behan, M. Sakil Syeed, Ammarin Thakkinstian, David C. Young, Nathorn Chaiyakunapruk
Asthma is a common, non-communicable disease of the lungs affecting both children and adults. It is estimated that 262 million individuals have asthma worldwide (1), although the prevalence varies among countries (2). Approximately 10–15% of individuals with asthma have moderate to severe asthma, with a reduced quality of life and an increased risk of exacerbations, health care resource use, hospitalization, and death (3). Patients with moderate to severe asthma have persistent symptoms or frequent exacerbations that may require repetitive corticosteroid bursts, maintenance oral corticosteroid therapy, or both, despite adequate treatment with short and long-acting beta-agonists, and long-acting muscarinic antagonists, and other alternatives like leukotriene receptor antagonists (4). In these patients, additional treatment, which may include biologic therapies (e.g. benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab, and tezepelumab), is needed to reduce the disease burden (3). Biologic therapies were found to have clinical benefits including reducing exacerbations and hospitalizations as adjunctive therapy to inhaled steroids (5). Moreover, they provide a more personalized and targeted treatment strategy to optimize effectiveness for patients with moderate to severe asthma. However, biologic therapies are relatively expensive. As a result, it is still unclear if using biologic therapies in patients with moderate to severe asthma is likely to provide a beneficial economic value.
Novel cannula design improves large volume auto-injection rates for high viscosity solutions
Published in Drug Delivery, 2022
Bruce C. Roberts, Christopher Rini, Rick Klug, Douglas B. Sherman, Didier Morel, Ronald J. Pettis
In recent decades, there has been rapid growth in biologic therapies for diverse chronic conditions including diabetes, rheumatoid arthritis, cancer, autoimmune diseases, and multiple sclerosis, among others (Jones, 2017; Bittner, 2018; Hu, 2020; Abolhassani et al., 2012). Biologic therapies are typically administered parenterally through intravenous (IV) or subcutaneous (SC) routes because effective oral delivery methods are not yet available (Wright, 2020). Subcutaneous injection using pre-filled syringes (PFSs) and/or autoinjectors (AIs) (Hu, 2020) is a well-established and effective route for drug administration and provides several advantages over IV delivery. Such devices enable self-administration by patients or at-home caretakers (Hudry, 2017; Ferguson et al., 2019; Bernstein, 2020; Frias, 2020), improve the convenience of therapy, and reduce time requirements and overall healthcare system costs (Rule, 2014; Jackisch, 2015; Olofsson, 2016; Jones, 2017).