BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science July 9, 2014

David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.

Alvotech & Teva Announce FDA Approval of  Biosimilar to Stelara April 17, 2024

STADA & Alvotech Secure Approval for Europe’s First Ustekinumab Biosimilar to Stelara January 10, 2024

Partners STADA and Alvotech recently announced the European Commission issued a marketing authorization for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab). The centralized marketing….

Enzene Biosciences Launches its First Manufacturing Base in the US, With Additional Plans to Establish Continuous Manufacturing Operations at its New Jersey Site January 8, 2024

Widely recognized as a pioneer in continuous manufacturing, Pune-based Contract Development & Manufacturing Organization (CDMO), Enzene Biosciences has announced the launch of its first manufacturing site in the US, located in….

SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023

Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.

Alvotech & Bioventure Announce Approval of AVT02 (Adalimumab) as Simlandi in Saudi Arabia January 24, 2023

 AVT02 as Simlandi is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure….

Alvotech Initiates Patient Study for Proposed Biosimilar for Eylea July 7, 2022

Alvotech recently announced the initiation of the company’s confirmatory clinical study for AVT06 (aflibercept), a biosimilar candidate to Eylea…..

AUTOINJECTOR TECHNOLOGY - De-risking Biosimilar Development With a Clinically Validated & Commercially Proven Disposable Autoinjector June 1, 2022

Victoria Meyer, MBA, explains how for many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.

Viatris Announces Receipt of First FDA Approval for Generic Version of Symbicort Inhalation Aerosol in Partnership With Kindeva March 16, 2022

MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect March 1, 2022

Angelos Stergiou, PhD, explains how the COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.

FDA Approves Samsung Bioepis & Biogen’s BYOOVIZ (SB11), LUCENTIS Biosimilar (ranibizumab-nuna) September 21, 2021

Samsung Bioepis Co., Ltd. and Biogen Inc. recently announced the US FDA has approved BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTIS (ranibizumab) for the treatment of neovascular….

Junshi & Coherus Biosciences Announce Positive Interim Results of CHOICE-01 Phase 3 Clinical Trial August 23, 2021

Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. recently announced positive interim results from the pivotal study CHOICE-01 (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating….

BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices March 29, 2021

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

Biogen Announces FDA Approval of PLEGRIDY (Peginterferon Beta-1a) Intramuscular Administration for Multiple Sclerosis February 4, 2021

Biogen Inc. recently announced the US FDA has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of….

BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications January 13, 2021

Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.

PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development October 1, 2020

Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.

CUSTOM DEVICE SOLUTIONS - Device Design Will Act as Competitive Distinguisher in a Post-Patent Expiry Biosimilar Market September 30, 2020

George I’ons dissects the different factors that will determine biosimilars’ adoption and pace of advancement against their original counterparts, namely clinical confidence in the biosimilar and patient confidence in the drug delivery device.

Samsung Bioepis Announces US Launch of Oncology Biosimilar for Early & Metastatic HER2-Overexpressing Breast Cancer & Metastatic Gastric Cancer April 15, 2020

Samsung Bioepis Co., Ltd. recently announced today that ONTRUZANT (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN (trastuzumab) for the treatment of….

BIOSIMILAR DEVELOPMENT - Biosimilar Biological Products: Development & Applications March 2, 2020

Kaiser J. Aziz, PhD, provides an in-depth overview of biosimilar products development and the evaluation criteria for FDA approval.

Pfenex Receives US FDA Approval for PF708 to Treat Osteoporosis October 10, 2019

Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…