Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 19, 2021.

Number 5: Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a 

Number 4: An advertisement for the Onpro wearable pegfilgrastim injector kit has the potential to undermine sales of biosimilars, the FDA stated in 

Number 3: China approved a product for rheumatoid arthritis and Crohn disease that Mabpharm and Sorrento Therapteutics said is an 

Number 2: Amgen's advertising appeared to 

 away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

Number 1: Just days after Bio-Thera announced initiation of a phase 3 study of patients receiving a candidate ustekinumab biosimilar, Samsung Bioepis said that it, too, 

 clinical trial for its own biosimilar version of the agent.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of July 19

Here are the top 5 biosimilar articles for the week of July 12, 2021.

Number 5: Presentations from the European Crohn's and Colitis Organization annual meeting 

 to adalimumab biosimilars and provided patient acceptance data.

Number 4: In a white paper, the International Generic and Biosimilar Medicines Association (IGBA) described 

 that it said affect market sustainability and patient access.

 as adalimumab biosimilars were sidelined by patent restrictions, said investigators who recommended patent reforms.

 with Teva Pharmaceutical Industries to commercialize a ranibizumab biosimilar candidate (FYB201) in the European Union, Canada, Israel, and New Zealand.

Number 1: Biosimilars are launching at significant discounts to reference products and 

 market share, according to a recent Amgen trends report.

The Top 5 Biosimilar Articles for the Week of July 12

On July 9, 2021, President Biden signed a sweeping 

 intended to promote a more vibrant and competitive economy. The mandate contained provisions that affect the biosimilars market.

For insight into the significance of these initiatives, The Center for Biosimilars® spoke with Chad Landmon, JD, chair of the Intellectual Property and FDA Practice groups at Axinn, Veltrop & Harkrider, a law firm specializing in antitrust and intellectual property issues based in New York.

The executive order calls for the importation of drugs from Canada to help improve supply and lower prices in the United States. It also directs HHS to support the use of generic and biosimilar agents, and it increases pressure on the Federal Trade Commission to oppose “pay-for-delay” agreements that pharmaceutical companies sometimes employ to keep rival products off the market.

Among its provisions, the executive order also calls upon HHS to produce a comprehensive plan within 45 days to address high prescription drug prices and “price gouging.”

Landmon put these initiatives into context with background information and insight into the likely pharmaceutical industry impact and response.

He discusses the complications inherent in tackling pay-for-delay settlements as these, while not ideal, do carry the benefit of offering parties to a pharmaceutical dispute a way to set a timeline for bringing products to market, thereby avoiding costly litigation that could prevent lower-cost drugs from entering the market for substantially longer periods of time.

Landmon mentions California’s landmark anti–pay-for-delay legislation, signed into law in 2019, that prevents “anything of value” from being exchanged by pharmaceutical companies in exchange for a settlement. This law survived its first legal challenge last year when a federal judge denied a motion for relief by the Association for Accessible Medicines (AAM), a group representing generics and biosimilars manufacturers.

The AAM in a statement issued July 9, 2021, said it is willing to work with the Biden administration to accelerate adoption of lower-cost generics and biosimilars but wants to avoid extension of restrictions on drug dispute settlements such as California has imposed. “The White House should ensure that any new regulations do not restrict the ability to settle patent litigation with brand companies in a procompetitive manner,” the AAM said.

Drug imports from Canada were authorized during the Trump administration. For a recent Center for Biosimilars® article outlining the pros and cons of this initiative, click 

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

Axinn IP Chair Provides Analysis of Biden Biosimilars Initiative

Here are the top 5 biosimilar articles for the week of July 5, 2021.

Number 5: Teva and Bioeq partnered on a ranibizumab biosimilar, Organon joined the Biosimilars Forum, and the Alliance for Patient Access issued 

Number 4: Hoping to stimulate greater use of biosimilars, 28 patient advocacy groups threw their weight behind 

 that would increase Medicare reimbursement to health care institutions when they prescribe biosimilars to patients.

 indicated that STADA Arzneimittel and Xbrane Biopharma’s ranibizumab biosimilar is as safe and effective as the reference product, suggesting regulatory approval may be on the horizon.

Number 2: Insulin aspart, lispro, and glargine biosimilar candidates referencing NovoRapid, Humalog, and Lantus 

 in trial data presented at the Scientific Sessions of the American Diabetes Association.

Number 1: Our roundup for June 2021 detailed some of the 

 to come out of the biosimilar industry this month, ranging from poignant business updates to reactions from key opinion leaders on regulatory decisions from around the world.

The Top 5 Biosimilar Articles for the Week of July 5

Here are the top 5 biosimilar articles for the week of June 28, 2021.

Number 5: The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) 

 for the ranibizumab ophthalmology biosimilar candidate, Byooviz (SB11), to be approved for marketing authorization.

Number 4: Sizeable savings per patient with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) were anticipated by a 

, investigators reported at this year's American Society of Clinical Oncology meeting.

Number 3: Authors of an opinion piece suggested that a 

 to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.

Number 2: Investigators determined that converting at least 2 patients with metastatic breast cancer to a trastuzumab biosimilar (Ogivri) could generate savings enough to 

Number 1: Cigna said that it is rolling out a 

 that, among its signature features, will offer patients a $500 health services/products gift card for switching to a biosimilar.

The Top 5 Biosimilar Articles for the Week of June 28

Here are the top 5 biosimilar articles for the week of June 21, 2021.

 that plaintiffs had no standing to challenge the constitutionality of the Affordable Care Act, saving the Biologics Price Competition and Innovation Act (BPCIA), which is the regulatory pathway for biosimilar approvals.

Number 4: Sophia Z. Humphreys, PharmD, MHA, explained how biosimilar utilization management 

 health care institutions to put COVID-19–related financial wreckage behind them.

Number 3: Real-world studies demonstrated 

 for trastuzumab biosimilars (Kanjinti and Zedora) vs the originator (Herceptin) and were presented at the ASCO 2021 Annual Meeting.

Number 2: Positive findings were reported for use of a bevacizumab biosimilar (Byvasda) in combination with sintilimab as a 

 for patients with advanced hepatocellular carcinoma (HCC).

Number 1: The “winner-takes-all” tender process for biosimilar procurement in the European Union 

 of driving competitors out of the market, authors of a new survey contended.

The Top 5 Biosimilar Articles for the Week of June 21

In this abbreviated interview, Senior Editor Tony Hagen talks with Tahir Amin, Dip LP, a former intellectual property attorney who is now co-executive director of I-MAK (The Initiative for Medicines Access and Knowledge), which lobbies to overcome unfair trade practices and make medicines more widely available to patients. He recently testified on AbbVie’s drug patenting and pricing practices before the House Committee on Oversight and Reform.

Amin talked about some of the concerning practices he witnessed during his early career in patenting. He said that patent filers will carefully word patents to allow for multiple ongoing filings. This enables them to build large portfolios of patents that represent legal tangles for biosimilar competitors.

Regarding patents for the reference product adalimumab (Humira), Amin said so many have been filed by AbbVie that it’s too costly and difficult for biosimilar developers to contest them all. This is a failing of the US patent system, he says, because these webs of patents cannot be undone.

He discussed Alvotech’s ongoing attempt to fight AbbVie patents on adalimumab and said he is hopeful that Alvotech will be successful, but he noted that Boehringer Ingelheim previously went to court with AbbVie over adalimumab and eventually settled. This, he said, demonstrates that the patent system is being “weaponized” by originator companies.

Amin described AbbVie as having a “drip feed strategy” in which it files for patents broadly and over time. Originator companies will carefully patent every aspect of biosimilar development they can think of, even if they are no longer using the process that they’re patenting, and this, too, serves as an obstacle to biosimilar competitors.

Additionally, Amin commended Representative Katie Porter (D-California) on her questioning of AbbVie’s CEO, Richard Gonzalez when he testified before the House Committee on Oversight and Reform. According to Porter, AbbVie is not spending as much as it claims on innovation. The company has previously defended the high price of Humira by saying that much of the revenues are reinvested in development of new products to improve the health and lives of Americans.

Originator companies may lose the idealism that leads to new and better products and, instead, simply focus on maximizing their current revenue stream from existing products, Amin said.

Amin talked about the history of the patent system from the 1950s through the 1980s, saying how innovation boomed in the 1950s and then in the 1970s an economic downturn led to a shift in priorities. He said that, today, 11 million patents have been filed and roughly 50% are likely “junk.” That large number of patents is being used as a measure of innovation, which Amin doesn’t think is right.

When asked about his hopes for the Patent and Trademark Office (PTO), Amin said the incoming director should take into account the public interest and effects of drug pricing because the PTO, he said, has never acknowledged the role that patents play in rising drug prices.

Finally, Amin discussed how the COVID-19 pandemic has underscored the patent system problems, because protection of intellectual property and corporate profits has impeded getting the vaccine out to everybody who needs it. However, the public health crisis is causing more people to engage with these issues, and Amin said that this could lead to policy changes that improve the patent system.

 to watch the full Deep Dive interview, only on Medical World News®.

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Activist Lawyer Discusses AbbVie and Patent System Shortcomings

Here are the top 5 biosimilar articles for the week of June 14, 2021.

 in conjunction with myelosuppressive chemotherapy (CTX) is safe, investigators conclude in findings presented at the ASCO 2021 Annual Meeting.

 of high-cost supportive care agents, suggesting that the value-based Oncology Care Model (OCM) is working.

Number 3: Postmarketing retrospective studies of the rituximab biosimilar (CT-P10, Truxima) demonstrate 

 with the reference product for treatment of diffuse large B-cell lymphoma (DLBCL).

Number 2: In a column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has 

 of originator biologics and improved patient access.

Number 1: A Matrix Global Advisors report states that the European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that 

The Top 5 Biosimilar Articles for the Week of June 14

® Senior Editor Tony Hagen interviews Anil Okay, chief commercial officer for Reykjavik, Iceland-based company Alvotech, which is developing multiple biosimilars in-house and forming global partnerships to market these agents once they receive regulatory approval and clear legal hurdles. Alvotech is also notable for its attempts to bring a high-concentration form of adalimumab (

) to market in the United States and the European Union.

Okay explains he considers citrate-free, high-concentration adalimumab to be a superior product to lower-concentration forms, and he expresses doubts about the strength of the market for these products in 2023, when as many as 6 lower-strength adalimumab biosimilars will launch.

Although Celltrion Healthcare (Incheon, Republic of Korea) aims to begin marketing its high-concentration adalimumab biosimilar (

) in the European Union this year, Alvotech hopes to become the first to market a high concentration adalimumab biosimilar in the United States, Okay says.

He also discusses Alvotech’s intentions to obtain an interchangeable designation in the United States for AVT02, which would facilitate substitution of AVT02 for the reference product (Humira) at the pharmacy counter.

Interchangeable designations require additional hurdles for FDA approval, but obtaining one is a marketing advantage and it’s likely a much faster route than waiting for the FDA to relax its policy on interchangeable requirements, Okay says, adding that interchangeability will resonate with end users. “It works at the end because it increases the uptake. It increases the confidence of the decision makers to switch to your product.”

Alvotech still must duke it out with Humira originator AbbVie over opposing 

 over high-concentration adalimumab biosimilar. These may delay market entry for AVT02.

Okay discusses Alvotech’s plans to broaden its slate of biosimilars for immunology and enter the primary care field of biologics, and he explains that Alvotech is somewhat hesitant to bring more biosimilars to the oncology sector given the rapid pace of drug development and the financial risk that newer, more powerful agents may emerge and displace products upon which biosimilars are based.

He also discusses Alvotech’s investment in bringing biosimilars to the China market, which currently is emerging yet dominated by local producers and developers, so much so that Pfizer recently backed out of a 

 investment in Guangzhou. Alvotech is partnering with local, well-established companies in China that Okay believes will employ their resources to successfully market Alvotech’s biosimilars.

The company is repeating this partnership formula in other markets across the globe, such as Brazil and Saudi Arabia, to gain footholds in distant markets.

A further marketing strategy Okay talks about is the development of automatic injectors to enhance the convenience of biologics administration and gain market share.“We believe nonprice attributes are equally important to differentiate our products in the market.”

Product differentiation, global partners, and a large suite of biosimilars in development are ways that Reykjavik, Iceland-based Alvotech expects to stay ahead of the competition. 

Alvotech Commercial Officer Discusses Biosimilar Marketing Strategy

In part 2 of this panel discussion with The Center for Biosimilars®, 3 experts explore strategies that India could take to improve the perception of its biologics and biosimilars.

Affordable Production and Perception Issues

Anurag Rathore, PhD, a professor in the Department of Chemical Engineering at the Indian Institute of Technology in Delhi, India, suggests several ways that India could reduce prices of biologics, including using multiple manufacturers. Additionally, Rathore says that switching from batch production to continuous processing could reduce manufacturing costs by 70% to 80%.

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, suggests that streamlining clinical trial requirements could help with affordability. He also states that he would like to see more transparency from India regarding cost and quality of biologics, such as a ranking system.

Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois, Chicago, and an entrepreneur, said that because regulatory agencies are in a learning phase, the biosimilars produced may not measure up to global quality standards.

Rathore comments on the length of time it’s taken for regulators in Asia to agree on bioequivalence standards for generic drugs and how that also applies to the biologics industry. He expresses concern that regulators could repeat past mistakes of taking too long to agree, which could lead to physicians being more hesitant to use biosimilars.

He suggests that India could adopt guidelines from the World Health Organization, the European Union, China, Japan, or the United States to develop their products and develop its own internal regulations over time.

Niazi remarks that Indian companies are developing too many biologics with different manufacturing techniques, which affects quality and consistency, but he believes that with motivation, these producers will eventually have an opportunity to participate in the broader market for biologics.

Rathore explains the difference between manufacturers that target global markets, who have a larger responsibility to follow international guidelines, and ones that target Indian or low- and middle-income markets.

He says that regulators need to get to a point where the size of the manufacturer doesn’t matter. He added that the evaluation process needs to be robust enough so that all products that receive approval are ones that should be allowed on the market and that there should be no room for error.

Cornes discusses biologics prequalification designations, which are general statements of support of a drug from the World Health Organization. These, he says, are a great idea to help lessen the workload for small- and middle-income countries when developing medications. However, he worries that the World Health Organization is mostly focused on essential medicines, meaning that prequalification determinations for other drugs could take a much longer time.

He suggests that shared common technical dossiers could be used as another standard and that he would feel comfortable with that. He says that if India could make policies like this happen, itwould be a very positive change.

In part 2 of this panel discussion, 3 experts on India’s biologics industry discuss whether biosimilars can be produced affordably in the country and ways of improving the industry’s image.