Biosimilars

05
Oct

GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections

On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry.  Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon.  Dr. Downey opened […]

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04
Oct

Chipping Away at 180-day Exclusivity:  A Good Discussion 

In a rousing session at the AAM’s GRx-Biosims conference, Kurt Karst, J.D., Director, Hyman, Phelps & McNamara, Brian McCormick, J.D., M.H.S., Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals, and Chad Landmon, J.D., Partner, Axinn, Veltrop & Harkrider LLP gave a presentation entitled 180-Day Exclusivity: What Is Past Is Prologue or, as they like to […]

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27
Sep

Mullin and Booker Introduce Bill for e-labeling – New Round Begins

Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously.  There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]

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25
Sep

Lachman Consultants to Participate at This Year’s GRx+Biosims 2023 in October

Join Lachman Consultants at GRx+Biosims™ 2023 in North Bethesda, MD, Oct 2 – 4 for three days of insights and engaging discussions around the most pressing issues vital to the generics and biosimilars industry. Lachman will be represented by several members of the team, including: Frances Zipp, President & CEO Bob Pollock, M.S., Outside Director […]

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21
Sep

Get Ready for a New Approach to cGMP Inspections

Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here).  Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections.  The proposed Guidance […]

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20
Sep

Bipartisanism Shows up at House Hearing on PBMs

Yesterday, the Committee on Oversight and Accountability of the House of Representatives issued a press release (here) after the hearing on Pharmacy Benefits Managers (PBMs) and their impact on drug pricing.  The press release is titled “Hearing Wrap Up: Pharmacy Benefit Managers Push Anticompetitive Drug Pricing Tactics to Line Their Own Pockets.”  I guess this […]

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18
Sep
Piggy bank on money concept for business finance, investment and saving

Generics and Biosimilars Reap Huge Saving to Consumers 

Once again, AAM reports the data from the IQVIA 2023 U.S. Generic and Biosimilar Medicines Savings Report (here) which demonstrates the savings power from generic drugs and biosimilars.  The Report indicates that, in 2022, the savings realized from the use of generic and biosimilars hit a record $408 billion, of which $9.4 billion was from […]

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01
Sep
Quality Management Maturity Document Released by FDA

Quality Management Maturity Document Released by FDA

The FDA issued a White Paper titled CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, designed as the next step in the evaluation of key quality assessments designed to identify a high level of commitment to quality management at a manufacturing firm. In the document, the FDA cautions that “Information […]

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