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BIOSIMILAR APPROVALS

Articles

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

European Commission Approves First Aflibercept Biosimilar

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Patient Surveys Provide Insight Into Real-World Adalimumab Biosimilar Use in IBD

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing

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Martin F. Dietrich, MD, PhD; Neil A. Abrahams, MD; Shirley M. Shiller, DO, AP/CP, MGP, FACP

Pathology Implications for CEACAM5 as a Therapeutic Target in Advanced NSCLC

William G. Wierda, MD, PhD; Andre H. Goy, MD

Community Practice Connections™:  B-Cell Tumor Board: Rendering Real World Personalized Treatment Plans in CLL/SLL and MCL Through the Lens of Emerging BTKi Evidence

Eleni Efstathiou, MD, PhD; Neeraj Agarwal, MD, FASCO; Evan Y. Yu, MD; Atish D. Choudhury, MD, PhD

Live “Hot Seat”: Experts Face Your Hot-Button Questions on Maximizing PARP Inhibitors in Patients With CRPC

David S. Boyer, MD; Tina Mac Donald, OD, CDCES, FAAO; 
Leo Semes, OD, FAAO


(COPE Credit) Community Practice Connections™: Advances in Geographic Atrophy – Optimizing Diagnosis, Monitoring Progression, and Increasing Communication with Transformative Treatment on the Horizon

Patient, Provider, & Caregiver Connection™

Brian Miller, MD, PhD, MPH; Joseph P. McEvoy, MD; Eric Zorn; Jan Zorn

Patient, Provider, and Caregiver Connection™: Individualizing Care for Patients with Schizophrenia—Understanding Patient Challenges and the Role of Innovative Treatment

Advances In: Integrating New Treatment Options into Management Plans for Patients with Moderate-to-Severe Atopic Dermatitis

2nd Annual IKA Keratoconus Symposium: Front Back and Everything in Between

Carla M. Davis, MD; J. Andrew Bird, MD; Sayantani Sindher, MD; Aikaterini Anagnostou, MD, PhD

Community Practice Connections™: Preparing for an Expanded Armamentarium for Food Allergy

William D. Chey, MD, AGAF, FACG, FACP, RFF; Lucinda Harris, MS, MD; Eric Shah, MD, MBA, FACG

Expert Illustrations & Commentaries™: A Closer Look at Emerging Therapies in IBS-C

2023 Annual Psychiatric Times™ World CME Conference

Advances in™ Congenital Adrenal Hyperplasia: Investigating the Impact of Emerging Agents

Navigating the Latest Data on NTRK-Targeted Therapies

Arshad M. Khanani, MD, MA, FASRS; Carl J. Danzig, MD, FASRS; Anat Loewenstein, MD, MHA

Community Practice Connections™: Novel Treatment Strategies in the Management of nAMD & DME - Lessons from Clinical Trial and Real-World Data

Myeloma Management Considerations: Applying the Evidence With Monoclonal Antibody Based Regimens

Dr Robert Busch, MD, FACS; Lucia M. Novak, MSN, ANP-BC, BC-ADM

PER Postgame™: Updates in Basal Insulin Therapy – Takeaways from the June 2023 Meeting on Diabetes

William G. Wierda, MD, PhD; Andre H. Goy, MD; Susan M. O'Brien, MD; Nicole Lamanna, MD

B-Cell Tumor Board: Rendering Real World Personalized Treatment Plans in CLL/SLL and MCL Through the Lens of Emerging BTKi Evidence

I. Paul Singh, MD; Danica J. Marrelli, OD, FAAO, AAO; Alena Reznik, MD; John R. Samples, MD

(CME Credit) Community Practice Connection™:   Pearls in Co-managing Glaucoma – Multidisciplinary Management in a Multitude of Treatment Options

Scott Urquhart, PA-C, DFAAPA; Wendy L. Wright, DNP, ANP-BC, FNP-BC, FAANP, FA; Brian Bizik, MS, PA-C

Respiratory Syncytial Virus: Understanding the Infection Burden and Anticipating the Impact of Vaccines

On-Demand Video Updates from the Annual Oncology Meeting

Leonard G. Gomella, MD, FACS; Daniel P. Petrylak, MD; Wenxin (Vincent) Xu, MD

Community Practice Connections™: 16th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

Hope S. Rugo, MD, FASCO; Sarah Donahue, MPH, NP; Kelly Shanahan; Hunter Turney

Patient, Provider and Caregiver Connection™: Addressing Patient Concerns During the Treatment and Management of HR+/HER2- Breast Cancer

Julie R. Brahmer, MD, MSc, FASCO, Deborah Doroshow, MD, PhD, Ticiana Leal, MD 

Community Practice Connections™: 20th Annual Winter Lung Conference

Michael Recht, MD, PhD, MBA; Rajiv K. Pruthi, MBBS; Annette von Drygalski, MD, PharmD, RMSK

Gene Therapy for Hemophilia B—The Next Step Forward in Disease Management

David R. Gandara, MD; Roy S. Herbst, MD, PhD; Karen Reckamp, MD, MS; Heather A. Wakelee, MD

Community Practice Connections™:  1st Annual Hawaii Lung: A Multidisciplinary Case-Based Conference™ 

Susan B. Bressler, MD; Sophie J. Bakri, MD, MBA; Judy E. Kim, MD, FARVO, FASRS

Medical Crossfire®: Considerations for the Use of Biosimilars in Retinal Disease - Are You Prepared for a New Paradigm? (CME Credit)

William J. Gradishar, MD, FASCO, FACP; Mark D. Pegram, MD; Erika P. Hamilton, MD; Hope S. Rugo, MD, FASCO

HER2+ Breast Cancer Tumor Board: Navigating Current and Evolving Strategies from Early Stages to Metastases

Alan E. Mast, MD, PhD; Allison P. Wheeler, MD, MSCI

BURST Expert Illustrations & Commentaries™: Tissue Factor Pathway Inhibition—A Visual Journey into the Science Behind Anti-TFPI Therapy for Hemophilia

Renato Ambrósio, Jr, MD, PhD; Tiffany Andrzejewski, OD, FAAO; Michael W. Belin, MD; Marc R. Bloomenstein, OD, FAAO; CAPT (Ret) John B. Cason, MD, MC, USN; Albert Y. Cheung, MD; Camille Cohen, OD, FAAO; Daddi Fadel, DOptom, FSLS, FBCLA, FAAO, FIACLE; Alan N. Glazier, OD, FAAO; Jennifer S. Harthan, OD, FAAO, FSLS; Kourtney Houser, MD; Timothy McMahon, OD, FAAO, Diplomate AAO; Clarke Newman, OD, FAAO, FBCLA, FSLS, FNAP; Mary Prudden, JD; Justin Schweitzer, OD, FAAO, Diplomate AAO; Louise Sclafani, OD, FAAO, FSLS; Christine Sindt, OD, FAAO; Uri Soiberman, MD; Loretta Szczotka-Flynn, OD, PhD, FAAO, Diplomate AAO; Stephanie L. Woo, OD, FAAO, FSLS; Andrew S. Morgenstern, OD, FAAO, FNAP

1st Annual IKA Keratoconus Symposium: Front to Back and Everything In Between

Mile Brujic, OD, FAAO; Jay Pepose M.D., Ph.D.

(CME Credit) Community Practice Connection™: Paradigm Shifts in Presbyopia – Understanding Advances in Topical Treatment Innovations

The Latest on Acute Lymphocytic Leukemia

BURST CME™: Utilizing Pathology Reports to Inform Treatment Plans Across GI Cancers

BURST CME™: What Is the Real Risk in Lower-Risk MDS?

BURST CME™: How Does Transfusion Burden Impact Real-World Outcomes in MDS?

Christopher C. Dvorak, MD; Matthias A. Karajannis, MD, MS; 
Kara M. Kelly, MD; Jacqueline M. Kraveka, DO

Clinical Vignettes: Inaugural International Congress on Pediatric Oncology

Evolving Treatments and Management Considerations for Patients with Hemophilia A

Recognizing Rett Syndrome Early to Improve Long-Term Management Outcomes

Rishi P. Singh, MD;  Ferhina S. Ali, MD, MPH; Yasha Modi, MD; Carl D. Regillo, MD, FACS

Medical Crossfire®: Expert Insights in Anti-VEGF Dosing for nAMD and DME – Optimizing Reduction in Treatment Burden

Peter Kaiser, MD; J. Fernando Arevalo, MD, PhD, FACS, FASRS; Nathan Steinle, MD

Community Practice Connections™: Expert Perspectives in Diabetic Macular Edema – Considering Pathogenesis & Inflammation in Treatment Selection

David R. Gandara, MD; Roy S. Herbst, MD, PhD; Heather A. Wakelee, MD, FASCO

24th Annual International Lung Cancer Congress®

Mile Brujic, OD, FAAO; David Kading, OD, FAAO, FCLSA; Selina R. McGee, OD, FAAO

The Ins and Outs of Lubricating Eye Drops

8th Annual Live Medical Crossfire®: Hematologic Malignancies

Roy S. Herbst, MD, PhD; David R. Gandara, MD; Lecia Sequist, MD, MPH; Gavitt Woodard, MD

Engaging the Multidisciplinary Care Team to Optimize Care of Patients With EGFR Mutation–Positive NSCLC: A Lung Cancer Tumor Board

Debra Castner, MSN, APRN-c, CNN; Osama W. Amro, MD, MS; Raeleen De Jesus, DNP, ANP-BC 

The Nephrology Nurse’s Role in Optimizing Outcomes for Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Nidal Moukaddam, MD, PhD; Dawn I. Velligan, PhD

Advances In™ Schizophrenia: Expanding the Therapeutic Landscape

John D. Gelles, OD, FIAO, FCLSA, FSLS, FBCLA; David S. Chu, MD

(COPE Credit) Clinical Crossroads:  Navigating Neurotrophic Keratitis – The Importance of Avoiding Pitfalls and Ensuring Early Intervention

41st Annual Miami Breast Cancer Conference®

A Focus on Acute Myeloid Leukemia

Andre H. Goy, MD; Nitin Jain, MD; Noopur S. Raje, MD

Community Practice Connections™: Pre-Conference Workshop on Immune Cell-Based Therapy

Justin Schweitzer, OD, FAAO; Inder Paul Singh, MD

Perfecting Co-Management of Glaucoma – Utilizing Development in the Spectrum of Treatment Options

Facing the Challenges of Implementing Palliative Care

Richard Kim, MD; John L. Marshall, MD; Mohamedtaki A. Tejani, MD; Rutika Mehta, MD, MPH; 

Community Practice Connections™:  8th Annual School of Gastrointestinal Oncology®

23rd Annual International Congress on the Future of Breast Cancer® East

Rita Nanda, MD; Heather McArthur, MD, MPH; Jennifer K. Litton, MD; 

Medical Crossfire®: Multidisciplinary Management of TNBC: Immunotherapy, PARP, TROP2, Oh My!

Alexander Drilon, MD; Karen Reckamp, MD, MS; Lyudmila Bazhenova, MD; Anjali Saqi, MD, MBA

Medical Crossfire®: Key Strategies to Prioritize Testing and the Evolving Role of Genomic Alterations in Providing Precision NSCLC Care

Heather McArthur, MD, MPH; Farnaz Dadmanesh, MD, FRCPC; Komal Jhaveri, MD, FACP; Hope S. Rugo, MD, FASCO

Community Practice Connections: Medical Crossfire®: How Have HER2-Low Expressing Breast Cancers and Novel Advances in the Field Redefined Care As We Knew It?

Updates in Myelodysplastic Syndromes

Kevin Kalinsky, MD, MS; Heather McArthur, MD, MPH; Hope S. Rugo, MD, FASCO; Debu Tripathy, MD

Medical Crossfire®: Optimizing Treatment Sequencing for HR+/HER2- Metastatic Breast Cancer Based on Emerging Evidence and Evolving Algorithms

Erica Stringer-Reasor, MD; Roberta Albany; Otis Brawley, MD; Karen M. Winkfield, MD, PhD

Identifying and Mitigating Disparities in Breast Cancer Care: Improving Diagnostics, Trial Access and Care for All Patients

Expert Illustrations and Commentaries™: A Deeper Look at the Pathogenesis of Hidradenitis Suppurativa (HS)

Live Patient, Provider, and Caregiver Connection™: Prevention and Control of Meningococcal Disease – Individualizing Vaccine Recommendations in Adolescent Populations

Sikander Ailawadhi, MD; Craig Cole, MD; Anita D'Souza, MD

Equalizing Inequities™ in Multiple Myeloma Care: Shining a Light on Current Barriers and Opportunities for Improved Outcomes

Reflective Case-Based Oncology Collective: Real-World Applications of Novel Therapies Across TNBC and Addressing Disparities in Care

Pamela B. Allen, MD, MSc; Stefan Barta, MD, MS, MRCP(UK); Jorge E. Cortes, MD; Andrew Evens, DO, MBA, MSc; Gabriela Hobbs, MD; Scott Huntington, MD, MPH, MSc; Elias Jabbour, MD; Tapan Kadia, MD; Rami S. Komrokji, MD; Nicole Lamanna, MD; Suzanne Lentzsch, MD, PhD; Marlise R. Luskin, MD MSCE; Matthew Matasar, MD; Alice Mims, MD, MSCR; Alison J. Moskowitz, MD; Jae H. Park, MD; Krina Patel, MD, MSc; Alexander Perl, MD, MS; Barbara Pro, MD; Noopur S. Raje, MD; Raajit K. Rampal, MD, PhD; Joanna M. Rhodes, MD, MSCE; Joshua Richter, MD; Jia Ruan, MD, PhD; Saad Usmani, MD, MBA, FACP; Peter Voorhees, MD; Amer Zeidan, MBBS, MHS 

7th Annual Live Medical Crossfire®: Hematologic Malignancies

Prateek Sharma, MD, FASGE; Felice H. Schnoll-Sussman, MD, MS

Expert Illustrations and Commentaries™: Advancing Care in Erosive Esophagitis: Towards a Path of Complete Healing

Do Patients with Multiple Myeloma Still Need Autologous Stem Cell Transplantation?

Jonathan Kay, MD; Steven R. Feldman, MD, PhD; 

"REEL" Time Patient Counseling™: Integrating Biosimilars into the Clinical Conversation

Catherine M. Broome, MD; Ilene Ceil Weitz, MD; David Kuter, MD, DPhil

Improving Outcomes in Autoimmune Hemolytic Anemias at the Intersection Between Hematology and Oncology Care

Sara A. Hurvitz, MD, FACP; Kevin Kalinsky, MD, MS; Elizabeth A. Mittendorf, MD, PhD, MHCM; Hope S. Rugo, MD, FASCO; Debu Tripathy, MD

Clinical Case Vignette Series™: 40th Annual Miami Breast Cancer Conference®

Mile Brujic, OD, FAAO; Cecelia Koetting, OD, FAAO, DipABO

(COPE Credit) Learning About the Lid – Optimizing Recognition, Diagnosis, and Treatment of Demodex Blepharitis & Blepharoptosis

New York GU 17th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

28th Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma

Robert Dreicer, MD, MS, MACP, FASCO; Celestia S. Higano, MD, FACP; Daniel P. Petrylak, MD

New Targets, New Treatments, and New Combinations for the Management of Advanced Prostate Cancer

Sigbjørn Berentsen, MD, PhD; Catherine Broome, MD

Community Practice Connections™: Enhancing Diagnosis and Management of Patients with Autoimmune Hemolytic Anemia

William D. Chey, MD, AGAF, FACG, FACP, RFF

Burst CME: Incorporating the Latest Updates in IBS Treatment into Your Practice

Komal Jhaveri, MD, FACP; Erika P. Hamilton, MD

Oncology Consultations®: Next Generation SERDs—Key Data and Practical Takeaways for the Community Physician

Grzegorz (Greg) S. Nowakowski MD; Kami J. Maddocks, MD; Ian Flinn, MD; Frederick L. Locke, MD



Medical Crossfire®: Exploring Hot Topics in DLBCL: Sequencing CD19-Targeted Therapies, Strategies Post-CAR T Relapse, Novel Agents, and More!

Aditya Bardia, MD, MPH; William J. Gradishar, MD, FASCO, FACP; Komal Jhaveri, MD, FACP

Community Practice Connections™: The Newest Frontier in HR+ Breast Cancer—Targeting ESR1 Mutations with Next-Generation Endocrine Therapy

(COPE Credit) Analyzing Novel Tear Stimulating Treatments for Special Populations in Dry Eye Disease

9th Annual School of Gastrointestinal Oncology® (SOGO®)

Anita Afzali, MD, MPH, MHCM, FACG, AGAF; William D. Chey, MD, AGAF, FACG, FACP, RFF; Bruce E. Sands, MD, MS; Bincy Abraham, MD, MS, AGAF, FACG, FASGE; Jordan Axelrad, MD, MPH; Abhik Bhattacharya, MD; Lin Chang, MD; Lucinda Harris, MS, MD; Sunanda V. Kane, MD, MSPH; Ali Rezaie, MD, MSc, FRCPC; Megan E. Riehl, PsyD; Kate Scarlata, MPH, RDN; Kyle Staller, MD, MPH; Thomas A. Ullman, MD; Zoë Gottlieb, MD; Eric Shah, MD, MBA, FACG

4th Annual Live Medical Crossfire® IBS and IBD

Patrick I. Borgen, MD; Joshua A. Feinberg, MD; Gary Schwartz, MD

Optimizing Pain Management for Breast Cancer Surgery Patients in the Age of the Opioid Epidemic

From Trials to the Real World: Assessing the Role of Allogeneic Transplant and JAK Inhibitors as Treatment Paradigms Evolve in Myelofibrosis

21st Annual School of Breast Oncology

7th Annual New York Cardio-Endo-Renal Collaborative (NY CERC)

Joyce O’Shaughnessy, MD; Aditya Bardia MD, MPH

Community Practice Connections®: Evaluating the Evolving Treatment Landscape for mHR+ Breast Cancer-How to Personalize Care and Improve Patient Outcomes