As you can imagine, getting established as a biotech boasting a unique expression system comes with its own set of challenges — especially when trying to enter a nascent biotech space in an emerging market. Here, one CEO discusses the strategies his company is exploring to gain buy-in on the company’s long-term goals in South Africa.
- 2 Efforts To Keep Payer Policies From Curbing Your Biosimilar’s Uptake
- 3 Healthcare Changes Biosimilar Companies Must Prepare For
- Biosimilar Competition: Not Your Grandmother’s Generics Market
- The Case For Optimism In The U.S. Biosimilar Market
- The Proposed Biosimilar Shared Savings Model: A Closer Look
- 5 Operational Priorities For Pharmas In The Wake Of COVID-19
- Biosimilars In Rheumatology: How To Move The Needle On Uptake, Access
The Case For Optimism In The U.S. Biosimilar Market
In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S.
5 Operational Priorities For Pharmas In The Wake Of COVID-19
Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!
Maybe Biosimilar Applicants Should Dance After All
The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.
Old Drug, New Tricks: Will The BPCIA Drive Generic Competition For Insulins?
High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.
Africa’s Biosimilar Landscape: Outlook & Current Challenges
Emerging markets, particularly Africa, represent an interesting case study for biosimilars. With a young population of more than 1.3 billion, Africa’s economy is the world's second-fastest growing, and the GDP is expected to grow to 3.9 percent in 2020 and 4.1 percent in 2021, according to the African Development Bank.
A New Guide For Promotional Labeling And Advertising Of Biosimilar Products
This article will outline the central components of new FDA guidance on promotional labeling and advertising considerations for biological reference and biosimilar products. While such materials are overseen by the FDA, the article also explores an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.
Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?
This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.
BIOSIMILAR WHITE PAPERS
Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.
Understanding And Controlling Raw Material Variation In Cell Culture Media
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
Developing A Scalable Process For Adenovirus Manufacturing
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Increasing Productivity In Hydrophobic Interaction Chromatography
In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.
Sensitive And Reproducible SPR-Based Concentration And Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO
An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The COVID-19 pandemic has thrown the entire pharmaceutical industry, as well as patients, providers, and sites of care for a loop. Though small molecule novel treatments and generics have seen much more pronounced impacts from market shut-downs and supply-chain disruptions, the biologics and biosimilars industry has also been striving to understand how the pandemic will alter availability and usage of biologic products. This collection of articles surveys a wide array of considerations facing biopharma and biosimilar companies, including the pandemic's impact on regulatory interactions, product supply and demand, materials sourcing, and market access and uptake.More Content Collections
LIFE SCIENCE EVENTS
Cleanroom Guangzhou Exhibition 2020
August 16 - 18, 2020
Understanding and Implementing the EU Regulation for Initiating and Conducting Clinical Trials
August 17 - 17, 2020
1pm-2:30pm EDT, Online Training
Aseptic Process Validation: Top-Tips for Compliance and Success
August 20 - 20, 2020
1pm-2:30pm EDT, Online Training
Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 Pandemic
August 24 - 24, 2020
1pm-2:30pm EDT, Online Training
Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation
August 25 - 25, 2020
1pm-2:00pm EDT, Online Training