The Pharma Data

JULY 3, 2025

Sunshine Biopharma Launches NIOPEG® Biosimilar in Canada, Targeting $10B Biologics Market Sunshine Biopharma Inc. and marks Sunshine Biopharma’s entry into the rapidly expanding global biologics and biosimilars market. The global market for NEULASTA® and its biosimilars is substantial. In 2024, it was valued at approximately $4.5

Marketing

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product.

Pharmaceutical Companies

thought leadership

MAY 29, 2025

The document, entitled Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications , applies to human drug applications and biosimilar biological product applications.

Biosimilars

FDA Law Blog: Biosimilars

APRIL 13, 2025

Accelerated approval requires companies to submit all promotional materials for their product thirty (30) days in advance of the material being used. Separately, these bloggers wonder whether the Untitled Letter to Taiho signals a specific focus on accelerated approval product promotion.

Drugs

Drug Channels

NOVEMBER 4, 2024

Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars.

Biosimilars

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands? How will the cuts at FDA impact inspections and enforcement? Will there be a heightened appetite for mergers and acquisitions in the space?

Compliance

Drug Patent Watch

MARCH 13, 2025

Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

Biosimilars

FDA Law Blog: Biosimilars

JULY 23, 2025

Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.

Government

FDA Law Blog: Biosimilars

APRIL 7, 2025

Indeed, most Center for Veterinary Medicine (CVM) Warning Letters arise because products advertised are actually new animal drugs. The Warning Letter alleged that the veterinarian product website made claims about a Vaccine Safety Study relied upon for approval that directly conflict with the PI.

Vaccine

Drug Patent Watch

FEBRUARY 18, 2025

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

Biosimilars

Drug Patent Watch

MARCH 5, 2025

The Future of Diabetes Care: How Biosimilar Insulin Products Are Revolutionizing Treatment As we continue to navigate the ever-evolving landscape of diabetes care, one thing is clear: innovation is key. And when it comes to insulin therapy, a game-changing trend is emerging: biosimilar insulin products.

Biosimilars

FDA Law Blog: Biosimilars

JULY 2, 2025

Types of matters include: Developing regulatory strategy for manufacturing and related issues that arise in product development programs. Our team assists clients with a wide variety of quality and manufacturing regulatory topics for drugs and biologics. Specifically, manufacturing/testing procedures and compliance with cGMPs.

Small Molecule

FDA Law Blog: Biosimilars

AUGUST 10, 2025

Although the OIRA notice provides few details on the nature of the rescission, it will almost certainly entail the removal of the nine words the LDT Final Rule added to the definition of “in vitro diagnostic products” in 21 C.F.R.

FDA

FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

Nonetheless, the medical products sector historically has drawn the lion’s share of attention at FDA, with the agency’s leadership ranks reflecting that priority. About 90% of the annual $4.1 trillion health care expenditure is attributed to managing and treating chronic diseases and mental health conditions.

FDA

Drug Patent Watch

APRIL 8, 2025

Product Pipeline : A robust product pipeline can drive growth and increase a company's valuation. Evaluate the number of products in development, their potential market size, and the competition. Consider the impact of new regulations, such as those related to biosimilars or generic drugs.

Pharma Companies

Drug Patent Watch

MARCH 20, 2025

Navigating the Complex World of Biosimilar Regulatory Agency Interactions As a biosimilar developer, you know that getting your product to market can be a long and arduous process. But how can you ensure that these interactions are effective and set your product up for success?

Biosimilars

FDA Law Blog: Biosimilars

MARCH 24, 2025

If rescheduled to schedule III, marijuana businesses would be required to obtain DEA registrations, take initial and biennial inventories of marijuana on-hand, maintain transaction records, file theft and significant loss reports, and label and secure products appropriately.

Regulations

FDA Law Blog: Biosimilars

MAY 4, 2025

IMC Pro agreed to provide the Chinese companies with access to the shipping companys accounts for common carriers to generate domestic shipping labels for goods and products the Chinese companies sold or manufactured. The government alleged that IMC Pro entered into business agreements with companies operating in China.

Packaging

FDA Law Blog: Biosimilars

NOVEMBER 18, 2024

The second part of Kennedy’s statement expresses concern that because companies are essentially paying the salaries of the review teams, that the teams somehow feel obligated to approve the products. On this second point, Kennedy elsewhere contradicts his own assertion that user fees lead reviewers to feel beholden to sponsors.

FDA

The Pharma Data

JUNE 6, 2025

CSOs allow pharmaceutical firms to scale sales operations rapidly , particularly during drug launches , geographic expansions , product lifecycle extensions , and co-promotion agreements. Biosimilars and Generics : Where cost competition necessitates strategic brand differentiation and efficient coverage.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

Newberger — Though digital health is not new, it can still often be difficult to determine with precision the regulatory requirements applicable to a particular software product. For example, many large tech companies market software products with heart rate and other vital signs monitors, and do not ask permission beforehand.

FDA

FDA Law Blog: Biosimilars

MARCH 6, 2025

The inclusion criteria may include elements such as, but not limited to, the patients age, weight, height, race, ethnicity, sex, and disease severity, consistent with the intended patient population for the final product, which may not be known in the early days in the sandbox. The DCP should address if there are missing data elements (e.g.,

FDA

FDA Law Blog: Biosimilars

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Pharmaceutical Companies

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. “2021 Generic Drug & Biosimilars Access & Savings in the U.S. What Are Generic Drugs? Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research Sources cited: U.S.

Drugs

Drug Patent Watch

APRIL 2, 2025

The Game-Changing Potential of Biosimilars in Population Health Management As healthcare professionals, we're constantly looking for innovative ways to improve patient outcomes and reduce costs. One area that's gaining significant attention is the use of biosimilars in population health management initiatives.

Biosimilars

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment.

Disease

FDA Law Blog: Biosimilars

MAY 27, 2025

We at HPM are optimistic that these listening sessions with CEOs can be equally impactful for product development. Given the recent sudden, frequent and often chaotic changes in the Agency, it is critical that the Commissioner hears directly from Industry about their goals, plans, and concerns.

FDA

FDA Law Blog: Biosimilars

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The conference equips legal professionals without prior regulatory experience, as well as life sciences executives involved with FDA-regulated products, with a comprehensive understanding of fundamental FDA principles. This is achieved through firsthand insights, real-world examples, and case studies from FDA-regulated products.

FDA

FDA Law Blog: Biosimilars

APRIL 8, 2025

Among other things, DPDs functions included: Facilitating the development, clearance, and publication of Product-Specific Guidances (PSGs). About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research.

FDA

FDA Law Blog: Biosimilars

JUNE 2, 2025

In the current RUO Guidance, FDA notes that the existence of an RUO certification program would only be viewed as a factor when assessing the intended use of an RUO product. These, along with the promotional claims formed FDAs basis for concluding the products were intended for diagnostic use.

FDA

Drug Patent Watch

MARCH 18, 2025

The Russian pharma market has experienced significant growth in recent years, driven by a combination of factors, including government support, increasing healthcare spending, and a focus on domestic production. One area that's gaining attention is the development of biosimilars. billion by 2025, with a CAGR of 10.5%.

Biosimilars

Drug Channels

APRIL 1, 2025

As youll see below, the combination of formulary exclusion and private labels is creating an increasingly confusing and crowded biosimilar marketplace. For 2025, the Big Three PBMs shifted national formularies to favor their private-label biosimilars over Humira and its many biosimilar competitors. What do you think?

Biosimilars

FDA Law Blog: Biosimilars

APRIL 10, 2025

In some cases, previously routine postings are delayed or going unpublished altogether. We also have heard from the remaining FDA FOIA staff that it could be at least a month before they can even provide a new estimate for when to expect responses under pending FOIA requests.

FDA

FDA Law Blog: Biosimilars

MAY 15, 2025

Industry can, however, expect smarter tailoring of regulatory frameworks by condition, product type, and risk. He delivered sharp words on tobacco and e-cigarette imports, warning that foreign manufacturers are gaming our porous border by importing products that would be illegal in their own countries.

FDA

FDA Law Blog: Biosimilars

JULY 13, 2025

Department of Agriculture Food Safety and Inspection Service who are responsible for inspecting meat, poultry, and eggs products, as well as ( certain ) fish. Granted, the fact sheet also does not specify whether “food inspectors” refers to FDA personnel who inspect food facilities and farms, and/or members of the U.S.

FDA

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

PMS requires manufacturers to gather information from various sources, evaluate the data for trends, and integrate the data into product development, risk management and design updates. In fact, the final guidance includes an example of a combination product in Appendix B.

FDA