Opinion
Biosimilars drug development: time for a paradigm shift?
Page: 17-22
Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared… Read More »
Biosimilarity is not a transitive property: implication for interchangeability, naming and pharmacovigilance
Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each… Read More »
Overview of non-innovator biological products in India
Abstract: As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered… Read More »
Why ‘similar’ can make a big difference
Abstract: This article explains what motivated the Digestive Cancers Europe’s (DiCE) recent position paper on biosimilar medicines for colorectal cancer. Submitted: 7 October 2019; Revised: 14 October 2019; Accepted: 15… Read More »
Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance
Author(s): Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB
Page: 84-91
Abstract: Biosimilar drugs have suffered slow entrance and acceptance rates in the US market, due not only to common misperceptions among the public but also US Food and Drug Administration… Read More »
Austrian medicines authority positive towards biosimilar interchangeability
Abstract: Clinical evidence supporting biosimilar use is growing and for the first time, the Austrian Medicines and Medical Devices Agency takes a positive position on interchangeability. They now state that… Read More »
Challenges of developing generics substitution policies in low- and middle-income countries (LMICs)
Author(s): Professor Mohamed Azmi Hassali, PhD, Zhi Yen Wong, BPharm (Hons), MSc (Pharmaceutical Policy), RPh
Page: 171-2
Abstract: There are few challenges to developing effective generics substitution policies in low- and middle-income countries (LMICs). These include the absence of generics substitution policies, lack of enforcement, lack of… Read More »
Is Australia positioned to take advantage of biosimilars?
Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small… Read More »
Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe
Author(s): European Biopharmaceutical Enterprises
Page: 188-92
Abstract: The European Medicines Agency (EMA) has led the development of biosimilar regulatory pathways globally, tailoring their approach to meet the specific and scientifically determined needs of biosimilar development. However,… Read More »