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.

Videos

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.

Part 2: Panelists Advise Patterning Guidelines on International Standards

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 June 7, 2021.

Number 5: Bio-Thera Solutions initiated a 

 clinical study for its golimumab biosimilar candidate (BAT2506) referencing Simponi.

Number 4: Organon said that it will do marketing but not research and development, Biogen and Bio-Thera 

 with a tocilizumab candidate, and Lupin promoted a pegfilgrastim biosimilar.

 of a trastuzumab biosimilar vs Herceptin in HER2+ (human epidermal growth factor receptor 2–positive) breast cancer.

Number 2: When biosimilars emerged in oncology, oncologists 

 and then got serious, according to a retrospective study on usage and savings presented at ASCO 2021.

Number 1: Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reported on his 

 to the FDA to rationalize testing of biosimilars.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of June 7

, 3 experts assess the state of the biosimilars industry in India and some of the biggest issues facing its success.

Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois, Chicago, contends that India’s guidelines involve requirements for unnecessary nonclinical data, such as from animal trials, and do not contain acceptable requirements for the number of patients needed to conduct a clinical study.

Anurag Rathore, PhD, a professor in the Department of Chemical Engineering at the Indian Institute of Technology in Delhi, India, states that a lot of India’s biologics issues aren’t necessarily with the guidelines, but are with guideline adherence, in that most regulators have specialized in small molecule drugs and have limited experience working with biologics.

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, explains why reducing biosimilar development costs without sacrificing clinically relevant data is important, including that most patients with cancer are from low- and middle-income countries, where affordable drugs are needed.

Rathore notes that India has tremendous skill already with producing safe and effective drugs because roughly half of the products on the US market are manufactured in India despite challenges. He agrees that it’s critical for India to manufacture biologics economically to improve affordability, but that it’s also important to improve the reliability of data coming from clinical trials.

Cornes states that India does have the resources to produce world class biosimilars but that he has concerns over whether there are too many small players and too much competition in the Indian marketplace, such that the large companies with the quality and resources to compete globally may find it hard to get the recognition they deserve. 

Niazi states that the standards put forth by the Central Drugs Standard Control Organization (CDSCO) are not optimal to allow for trial data to be accepted worldwide, which results in a lot of Indian companies doing only what is needed to receive approval in India. This means that none of the locally produced biosimilars sold exclusively in India could qualify for use in Western countries without companies having to redo their trials from scratch.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally. 

Part 1: Panelists Suggest More Groundwork Is Needed for Indian Biologics to Achieve Global Market Access

Here are the top 5 biosimilar articles for the week of May 31, 2021.

 for an ustekinumab biosimilar candidate (BFI-751) referencing Stelara, an immunosuppressant for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

 in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

Number 3: Investigators reporting on insulin availability in the Philippines said affordability and access are inadequate for many in the country and recommended 

Number 2: Febrile neutropenia (FN) in patients undergoing chemotherapy has long been counteracted with granulocyte colony-stimulating factor (G-CSF) drugs. Models of G-CSF biosimilar use in this setting suggest not only significant savings but also potential for 

 in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

The Top 5 Biosimilar Articles for the Week of May 31

The Center for Biosimilars® recently spoke with Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium (BBCIC), about biosimilar utilization, the possibility for the first interchangeable biosimilar, and the need for more real world evidence.

Lockhart discussed the granulocyte colony-stimulating factor (G-CSFs) drug market, which includes filgrastim and pegfilgrastim biosimilars. Although infliximab biosimilar uptake has been slow, G-CSF biosimilars are considered a success story, in that utilization trends for these products are trending upward.

She predicted significant evolution of the biologics market as more anti–tumor necrosis factor products and biosimilars are launched. Further, she noted that in the anti-inflammatory space, there are a number of nonbiosimilars and new originator products emerging. This trend will affect the utilization of biosimilars, she said. 

Lockhart also described the prospect for the first interchangeable biosimilar insulin (Semglee) as exciting, because it holds the potential for lower costs of insulin and some other interesting market dynamics.

The quality and availability of real world evidence has improved in recent years, although in some cases the data being used for assessment of clinical trends were not gathered for that purpose and so are not ideal, she said. The BBCIC and other organizations have worked to enrich the quality of these data so that the utility is more relevant to needs.

In part 2 of this interview, Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, discusses the potential for interchangeable insulin biosimilars and the challenges of obtaining reliable and optimized real world data.

Cate Lockhart: Putting the US Biosimilar Industry in Perspective

Here are the top 5 biosimilar articles for the week of May 24, 2021.

Number 5: Biosimilar developer Prestige BioPharma said 

 a $152 million research and development facility measuring 45,000 square meters in the Republic of Korea.

Number 4: Zydus Cadila launched the world’s first biosimilar form of 

, an antibody drug conjugate that both counteracts cancer cell growth and delivers a cytotoxic agent to the cancer cells and helps to destroy them.

 to prescribe biosimilars instead of costly originator products, panelists said in a Sandoz/Reuters discussion.

 Canadian province to implement a mandatory biosimilar switching program. With some exceptions, the province is switching to a policy of allowing only biosimilars, if available, on lists of approved biologics.

Number 1: A study funded by AbbVie finds 

 patients on originator rheumatic agents, such as Humira (adalimumab), rather than switching to biosimilars.

The Top 5 Biosimilar Articles for the Week of May 24

The Center for Biosimilars® recently spoke with Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, about the infliximab market, the pipeline of biosimilar products on the horizon, and the need for more real world evidence.

In the interview, Lockhart talks about how infliximab biosimilars have seen tepid acceptance in the United States compared with other countries, achieving only 7% uptake despite being some of the first biosimilars on the US market.

Although she said it’s unclear what would change the game for infliximab biosimilars, she noted that other biosimilars have achieved higher usage, suggesting that more broader uptake overall will become the standard trend.

She also discussed the biosimilars pipeline that currently has more than 70 potential products. Lockhart said slow uptake for infliximab biosimilars might have discouraged some companies from pursuing biosimilars, but seeing how robust the pipeline currently is makes her hopeful that more candidates will receive FDA approval, especially as the COVID-19 pandemic continues to wind down in the United States.

Lockhart also explained how more real world evidence on use of biosimilars could help alleviate persuade more physicians to prescribe these products. She added that policy guidances can be ambiguous and that real world evidence can play an important role in informing decision makers.

Additionally, Lockhart said that real world evidence could provide payers an alternative evidence source to traditional clinical trials, enabling them to feel more comfortable with biosimilars and better inform their formulary decision making.

In part 1 of this interview, Cate Lockhart, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, details some of her expectations for further growth of the US biosimilar market.

Cate Lockhart: Is There Hope for a Robust Biosimilar Industry in the United States?

The Center for Biosimilars® spoke recently with Ping Cao, vice president of Business Development for Shanghai Henlius Biotech about the company’s business activities and conditions for biosimilar developers in the Chinese market. Established in 2010, Henlius is notable for having brought the first biosimilar to the Chinese market, a rituximab product. Henlius has a robust pipeline of products and ambitions to partner with companies abroad for global sales development.

In the interview, Cao talks about recent changes in Chinese guidance for biosimilar development and how these have quickened the pace of approvals and improved conditions for companies entering these markets. For example, previously it may have taken 3 years from the time of an investigational new drug (IND) application to gain regulatory approval to commence a clinical trial. That timeline has been shortened to 60 days under the new regulatory standard in China, which has established timing guarantees that allow companies to proceed if they do not receive a response to IND applications within 2 months.

In this sense, the Chinese government has been an active partner with the biologics industry and has extended opportunities for talks with the business sector on how to further improve the regulatory system. This bodes well for the future of biosimilars development and marketing, Cao explains.

Cao also provides a comparison of the regulatory environments in the United States and China and discusses the competitive dynamics of producing biosimilars and gaining market share as the number of competitors and competing products continue to increase. For Henlius, the costs of producing a biosimilar can range up to $100 million, and to meet regulatory standards in the United States and European Union, the costs could go higher than that, Cao explains. Meanwhile, producers need to keep their biosimilar prices competitive with what others are charging. Therefore, these 2 dynamics—cost of production and pricing—may move on opposing trendlines.

Cao also talks about the promising market in China for the company’s adalimumab biosimilar (referencing Humira), which was approved by China’s National Medical Products Administration in late 2020 for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Within China, Henlius has an extensive network of hospital partners and a large sales team, with which the company believes it can reach a population exceeding 6 million patients in China.

For more reading about Henlius’ biosimilars portfolio, pipeline, and global development ambitions, click 

China’s streamlined system for biologics approvals has enabled Shanghai Henlius Biotech to bring biosimilars to market faster and potentially at a lower cost, Ping Cao, vice president of Business Development, explains. 

Part 1: Henlius Executive Discusses China’s Biologics Market

Here are the top 5 biosimilar articles for the week of May 17, 2021.

Number 5: Various House members have asked the Federal Trade Commission (FTC) to open an antitrust investigation into pharmaceutical giant AbbVie, which allegedly has exceeded its patent rights in preventing biosimilar competition to arthritis drug Humira (adalimumab) in the United States.

Number 4: Investigators in Germany said that a comparison of adalimumab biosimilar (Amgevita) vs originator (Humira) treatment for patients with rheumatoid arthritis has demonstrated 

Number 3: Sandoz has lost a bid to bring its etanercept biosimilar to market before 2029, as the Supreme Court 

 the company’s petition to invalidate 2 patents held by Amgen for the reference drug, Enbrel.

Number 2: With the pandemic tapering off in the United States and its sales force vaccinated, Coherus BioSciences hopes that returning its sales representatives to the field this spring will counter 

 of its pegfilgrastim biosimilar (Udenyca).

Number 1: The FDA’s interchangeability designation for biosimilars was intended to improve uptake and acceptance of these agents, but so far it has created 

, according to Albert Kim, MBA, vice president of the Commercial Division at Samsung Bioepis.

The Top 5 Biosimilar Articles for the Week of May 17

Here are the top 5 biosimilar articles for the week of May 10, 2021.

Number 5: During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for a 

 to bring biosimilars to market sooner with less expense and wasted effort.

, and Organon executives discuss the growth potential of the planned Merck spinoff.

Number 3: Fighting back against a suit that alleges theft of trade secrets, Alvotech has filed suit against AbbVie alleging that key patents for its blockbuster adalimumab drug (Humira) 

 partly on grounds that AbbVie did not invent the processes that were patented.

 of biosimilar availability in the European Union, and in an overview sponsored by Medicines for Europe, experts from regulatory and business venues discussed some of the major achievements and hurdles yet to be crossed.

 into the anatomy of a biosimilar switching study reveals what it takes for a biosimilar to be approved as interchangeable in the United States.