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Feb
2
Sandeep Singh Dhillon
What Challenges Should Biosimilar Companies Expect In 2018? – Biosimilardevelopment.com
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By Anna Rose Welch, Editor, Biosimilar Development

What challenges do you expect biosimilar companies to run into in 2018, and what could be done to address these challenges?

A sustainable biosimilar medicines industry implies access to the global market, or at least a multi-region market. In the EU, the European Commission will undertake a debate on pharmaceutical incentives, which is a cornerstone to competition in the pharmaceutical and biologics market. One of the measures at stake, the supplementary patent protection manufacturing waiver, is of fundamental importance for biosimilar manufacturers established in the EU. The change would leave the EU IP landscape unaffected while, at the same time, enabling manufacturers to compete globally for markets where IP protection no longer exists, removing an unintentional adverse effect of the current legislation. This is particularly important in light of the key biologic product monopolies for which expiry is coming. The biggest of all challenges, in my opinion, will be for EU governments and policy makers to put their ambitions in motion, be it for competition in the biologics market or for EU industrial policy. Rather than grand plans and national policies, it may be important to start with small and tailored, yet concrete, policies so the benefits are tangible in a shorter time frame.

Julie Maréchal-Jamil, director biosimilars policy & science, Medicines for Europe

An ongoing challenge for companies will be considering commercialization challenges and solutions as well as policy and reimbursement trends and scenarios from the moment of product selection. Too many companies have focused entirely on selecting, developing, and investing in products alone, but this is not enough. Companies also have to build a strategy around a true path for differentiation and be clear as to what parts of the value chain will be owned by whom. Hence, you have to engage business development much earlier in the process. Waiting too long to do so greatly lowers options and returns while increasing risks and the possibility of early mistakes, even as far back as portfolio selection itself. In short, development and regulatory success are necessary but certainly not sufficient. One must engage more fully and proactively in policy and commercialization challenges and solutions — not just alone, but with partners and trade associations.

Edric Engert, managing director, Abraxeolus Consulting

Biosimilars will enable patients with active rheumatoid arthritis and inflammatory bowel disease to get the treatment in its early stages. For patients with lymphoma or breast/gastric cancer, biosimilars can improve access to therapeutically aggressive rituximab- or trastuzumab-based combination regimens. However, physicians and patients continue to emphasize concerns about switching from biologics to biosimilars. Therefore, biosimilar companies must have robust evidence to reassure the medical and patient community about the safety and efficacy of switching. For instance, studies like the NOR-SWITCH study or the pivotal randomized controlled trial of CT-P13 in Crohn’s disease have made a significant contribution to the evidence base for switching.

— HoUng Kim, head of strategy and operations, Celltrion

Market access remains a challenge for biosimilar companies, with patients, pharmacists, and physicians still unsure about biosimilars. Knowledge about and understanding of biosimilars and their development pathway are still lacking, and more education is required at a broader and deeper level. Stakeholders such as payers, regulatory agencies, and others in the healthcare sector should actively promote the use of biosimilars, explaining how they can promote sustainability of the healthcare system. In the EU, gainsharing has certainly helped the uptake of biosimilars, whereby the savings generated by patients taking biosimilars are shared between providers and payers. This acknowledges the efforts by providers in either initiating or switching patients to a biosimilar.

Sue Naeyaert, global head of pricing, market access, government affairs and policy, biosimilars, Fresenius Kabi SwissBioSim

One main challenge I expect biosimilar companies to run into in 2018 will be effectively balancing pricing that will enable profits and gain commercial payer reimbursement and management support. Biosimilar companies may face challenges to provide lower net-cost pricing relative to competing reference biologics in order to gain support from some commercial health plans. It is important to note this challenge does not apply to Medicare, because Medicare Advantage plans are restricted from providing utilization management support (though this actually could help increase market share for Part B biosimilars).

— Brian Lehman, strategic consultant, Humana Pharmacy Professional Affairs

One of the big challenges at the moment is finding enough patients to accommodate the requirements for clinical trials, seeing as more companies are bringing mainstream biosimilar drugs, such as anti-inflammatory drugs, into Phase 3 clinical trials. One way to address the challenge is by accessing patients in other geographic locations who haven’t been treated with these drugs, such as Eastern European countries, where the quality of medicine is high and standardized laboratory tests can be run at another site, such as in Western Europe. In the U.S., administrative burdens, such as documentation requirements and physician sign-off, can interfere with supporting patients in a clinical trial. This challenge could be addressed by streamlining the documentation required and presenting a harmonized approach to data collection and reporting, with support from regulatory agencies and industry associations.

Don Stewart, CEO, PlantForm

Patent litigation will continue to dampen the growth of the biosimilar market in the U.S. I’d argue public interest litigation and political pressure would help the situation. In general, a stronger biosimilar lobby would help significantly.

Pankaj Mohan, CEO, Oncobiologics

In my opinion, the greatest challenges biosimilar companies will face in 2018 are acceptance, patent challenges, and developing a successful marketing plan. A critical challenge facing biosimilar companies will be to educate the broader healthcare professional community and then patients about the basics of biosimilars. By necessity, education has until now focused on some professional societies and patient groups. While it is heartening to see an increase in their knowledge and acceptance, it will be more challenging to broaden this knowledge to the rank and file of healthcare professionals and to the ordinary patient so that biosimilars will be broadly accepted.

It has also become apparent that the thicket of patents surrounding reference products will delay the entry of many biosimilars. I am not an expert on patents, but still I recognize that negotiating a path forward in this area will be critical. Adoption of biosimilars in the U.S. once they are launched will also be a challenge. Zarxio has a very respectable market share two years after product launch, but it seems other biosimilars are facing challenges in adoption.

— Hillel Cohen, executive director, scientific affairs, Sandoz

*These statements represent the viewpoints of the individuals, not those of their employers.

This article originally appeared at https://www.biosimilardevelopment.com/doc/what-challenges-should-biosimilar-companies-expect-in-0001?vm_tId=2047638&user=c666d828-d506-40aa-bb3a-c74525efd4db&utm_source=et_6384992&utm_medium=email&utm_campaign=BIOS_02-01-2018&utm_term=c666d828-d506-40aa-bb3a-c74525efd4db&utm_content=What+Challenges+Should+Biosimilar+Companies+Expect+In+2018%253f

Feb
16
Sandeep Singh Dhillon
CCM Duopharma seeks to commercialise erythopoietin for kidney failure treatment – Edge Malaysia
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KUALA LUMPUR (Feb 15): CCM Duopharma Biotech Bhd will begin the registration for commercialisation of its erythopoietin (EPO) biosimilar, which will be beneficial in the treatment of anaemia in end-stage kidney failure patients.

This follows the completion of a two-year clinical trial totalling RM17.5 million in investment cost by its wholly-owned subsidiary Duopharma (M) Sdn Bhd (DMSB) with South Korea-listed PanGen Biotech Inc. CCM Duopharma’s parent Chemical Co of Malaysia Bhd (CCM) has a 9.34% stake in PanGen.

Through its investment in the trial, CCM Duopharma said it obtained commercialisation rights for product marketing and distribution of the EPO biosimilar in Malaysia, Singapore and Brunei.

“The product is expected to be launched once marketing authorisation has been received from the National Pharmaceutical Regulatory Agency,” it said in a statement today.

CCM Duopharma noted that it will be the first Malaysian company to co-develop a biotherapeutic product and the second epoetin-alfa biosimilar to be developed globally.
 
According to the group, the clinical trial involving 228 patients in Malaysia and 70 patients in South Korea, was a multi-centre, multi-national, double-blind, randomised, active-controlled parallel-group clinical study to assess the safety and efficacy of PanGen’s EPO product (codenamed PDA10) in patients with anaemia arising from chronic renal failure.

“PDA10 showed similar efficacy and safety to the innovator drug demonstrating equivalence in terms of pharmacokinetics, pharmacodynamics and toxicity,” said CCM Duopharma.

PDA10, PanGen’s first commercial biosimilar finished product is an erythropoietin produced in cell culture using recombinant DNA technology and is responsible for the production of human red blood cells.

“The completion of the Phase III trials is a significant milestone for us as we expand our focus on biosimilars while indirectly assisting in the development of the Malaysian biopharmaceutical industry. It will also enable us to offer more affordable treatment options for patients without compromising their safety and efficacy,” said CCM group managing director and CCM Duopharma chief executive officer Leonard Ariff Abdul Shatar.
 
“Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry of the innovator product,” said CCM Duopharma.
 
“The biosimilars business, which is dominated by global pharmaceutical players, is expected to expand at a compounded average growth rate of 12% in Asia to an estimated RM8 billion in Southeast Asia by 2020,” it added.

CCM Duopharma shares closed down two sen or 0.92% at RM2.16 today, bringing a market capitalisation of RM602.55 million. PanGen’s stock also closed 1,350 won or 7.54% lower to 16,550 won, with a market cap of 149.75 billion won.

Dec
8
ragupathyrenganathan
There’s a new type of medicine that could save the US billions over the next decade — but not everyone wants that to happen
Drug Discovery, Formulation Discussion
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Dec
2
ragupathyrenganathan
Getting to Know Biosimilars – Courtesy of Pharmaceutical Manufacturing
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In March 2015 the U.S. FDA approved Zarxio (filgrastim-sndz), the United States’ first biosimilar product to earn the distinction. According to the FDA, Sandoz Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), originally licensed in 1991. At the time FDA Commissioner Margaret A. Hamburg, M.D., explained “Biosimilars will provide access to important therapies for patients who need them. Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

Zarxio’s approval, said the FDA, is based on review of evidence that included structural and functional characterization, animal study data, pharmacokinetic and pharmacodynamics data plus clinical immunogenicity data and other clinical safety and effectiveness data. Under the BPCI Act, a biological product that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

Rand Corp.’s study, “The Cost Savings Potential of Biosimilar Drugs in the United States,” notes “the introduction of biosimilars is expected to reduce prices, albeit to a lesser degree than small-molecule generics.” Rand’s analysts explain this perspective combines prior research and recent data to estimated U.S. market cost savings. “We predict that biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, or about 4 percent of total biologic spending over the same period, with a range of $13 billion to $66 billion.” At the time of the study’s release Rand added this caveat: “Actual savings will hinge on the specifics of the final FDA regulations and on the level of competition.”

Forbes magazine contributor David Kroll succinctly reported a bit of truth last March: “… it’s fair to say that manufacturing a biologic agent that acts similarly to the original branded drug is an order of magnitude more difficult and has more places where it can go wrong.” No kidding. It takes a highly competent, experienced player to succeed, and that’s why Seeking Alpha’s analysts singled Amgen out as one biopharmaceutical company well-poised to be an early biosimilars champion.

Amgen has three Phase III candidates right now, including ABP 215, its answer to bevacizumab (Avastin), developed and currently marketed by the Genentech arm of Roche; ABP 980, Amgen’s biosimilar answer to Herceptin, another Genentech/Roche blockbuster; and ABP 501 currently under trial for moderate to severe rheumatoid arthritis, targeting the replacement of AbbVie’s Humira. Seeking Alpha says Amgen’s IPR petition against Humira patents could set a precedent for biosimilars in patent law going forward.

Seeking Alpha says when Amgen reported its second-quarter 2015 results in its earnings call, the company reiterated its focus on biosimilars. “According to a 2014 analysis, it costs Amgen somewhere in the region of $200 million to develop a biosimilar, compared to the average cost-to-market of a new pharmaceutical treatment of $2.6 billion.” The point being that companies with experience innovating and processing biologics have a real leg up when it comes to manufacturing economics, but also the ability to price competitively, and to some minds that might mean more fairly as well.

For full article, visit: https://www.pharmamanufacturing.com/articles/2015/getting-to-know-biosimilars/

Nov
23
ragupathyrenganathan
Freshers Job @ Biocon as Executive in Biosimilars Production ! Multiple Vacancies Available | Apply Online !
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Jun
16
sandeepsd
Not ready to benefit from biologics and biosimilars
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THE market for biological drugs is stirring as the patents for many products are about to expire, but local pharmaceutical players are generally not ready to take advantage of the opportunities opening up. Read more …

May
25
ragupathyrenganathan
BIOSIMILARS: SCALE UP FROM R&D TO COMMERCIAL STAGE
Formulation Discussion
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May
25
ragupathyrenganathan
FDA Releases Draft Guidance on Biosimilars
Intellectual Property Rights
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May
25
ragupathyrenganathan
Judge Finds Biosimilar Patent Procedures Optional – Courtesy (Pharma Patent)
Intellectual Property Rights
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May
25
ragupathyrenganathan
Amicus Briefs On Biosimilar Patent Litigation – Courtesy (Pharma Patents)
Intellectual Property Rights
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