The Center for Biosimilars

MJH Life Sciences™, owner of The Center for Biosimilars

, has announced it has acquired the Pharmacy Benefit Management Institute (PBMI) from Pharmaceutical Strategies Group (PSG). This latest addition to the MJH portfolio broadens its leadership position in managed care at a crucial time for medicine in our country.

“Credible information is critical to healthcare professionals during this global pandemic, and education about how it will impact drug benefit management is vital,” said Mike Hennessy Jr., president and CEO of MJH Life Sciences™. “For 25 years, PBMI’s annual meeting has been a driver of change within the marketplace, and as part of our Managed Markets Network, we look forward to growing the conference to make an even bigger impact in the field of managed care.”

As the leading provider of research and education for the pharmacy benefit market, PBMI informs, advises, and influences the industry on drug cost management. PBMI provides a forum for purchasers to exchange ideas and drive marketplace changes that improve pharmacy benefits and control costs. The company offers a wide range of services, including research, continuing education and web resources to help all critical stakeholders work better together to optimize the overall value of drug benefit programs. PBMI is based in Plano, Texas.

“We are appreciative of the many years we have worked in partnership with PBMI,” said Dave Borden, CEO of PSG. “We are proud to have provided a home for PBMI to fulfill its mission to provide quality information and education around best practices and cutting-edge clinical and drug cost management strategies and solutions in community with the industry associates, PBM partners, and PSG friends and colleagues who have supported PBMI conferences and events.

“After careful consideration, we have decided to give PBMI a new home where it can continue its mission and prosper for many years to come,” Borden added. “MJH Life Sciences™ is a global business with significant resources and experience in the area of conference management and education, and we are confident the organization will enable PBMI to further its mission and reach new heights. We look forward to continuing our relationship with PBMI and hope to see our friends, partners, and colleagues at PBMI events for many years to come.”

The sale includes PBMI’s trademarks, conference, website, education and membership assets. All current and future research and analytics projects will continue through PSG under the leadership of Sharon Frazee, Ph.D., MPH, SVP Research & Data Innovation.

 is the largest privately held, independent, full-service medical media company in North America dedicated to delivering trusted health care news across multiple channels, providing health care professionals with the information and resources they need to optimize patient outcomes. MJH combines the reach and influence of its powerful portfolio of digital and print product lines, live events, educational programs and market research with the customization capabilities of a boutique firm. Clients include world-leading pharmaceutical, medical device, diagnostic and biotech companies. For more information, please visit 

The Pharmacy Benefit Management Institute (PBMI) is the nation’s leading provider of research and education that informs, advises and influences the industry on drug cost management. For more information about PBMI visit 

 is a leading website for news and information on developments in the biosimilars industry. With news articles and insightful features on business and clinical developments, conference coverage, expert commentary, and interviews with key opinion leaders, The Center for Biosimilars

 keeps readers and viewers around the globe informed and up to date.

Articles

MJH Life Sciences™, owner of The Center for Biosimilars®, has acquired the Pharmacy Benefit Management Institute (PBMI), the nation’s leading provider of research and education that informs, advises, and influences the industry on drug cost management.
 

Pharmacy Benefit Management Institute Acquired by MJH Life Sciences

Shanghai, China-based Henlius Biotech said its investigational new drug application for a denosumab biosimilar has been accepted by the National Medical Products Administration (NMPA) of China. The agent is indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture.

The biosimilar, HLX14, is a recombinant anti-receptor activator of nuclear factor kappa B ligand (RANKL) human monoclonal antibody injection. The reference product is Prolia.

HLX14 can specifically bind to RANKL and block the interaction between RANKL and RANK, which is expressed on the surface of osteoclasts, thus inhibiting RANKL/RANK-mediated differentiation, and maturation and activation of osteoclasts, thereby reducing bone resorption and the incidence of skeletal-related events.

The Henlius pipeline includes the biosimilars HLX03, an adalimumab injection, and HLX02, trastuzumab for injection, which currently are in the new drug application stage with the NMPA.

The originator drug Prolia has been approved in the United States and Europe for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. It is also indicated for patients with giant cell tumor of bone and patients with osteoporosis at high risk for fracture.

Denosumab can increase the bone density and reduce the risk of fracture. In China, denosumab has already been approved for giant cell tumor of bone that is unresectable or in cases where surgical resection is likely to lead to severe morbidity. But indications for osteoporosis have not been approved yet.

“Nowadays, the serious problem of osteoporosis is arising throughout the world. Among all countries, China has the largest population that is suffering from osteoporosis, which mainly occurs in postmenopausal women and elderly people,” Henlius said in a 

The company notes that osteoporosis leads to loss of quality of life and the population of patients in China who have access to standard of care is low, which means there is a large and urgent unmet need in the treatment of this condition.

Denosumab also has a US indication for the treatment of bone metastasis from solid tumors, Henlius said. In breast cancer, the relative incidence of bone metastasis is 65% to 75%; prostate cancer, 65% to 75%; thyroid cancer, 60%; lung, 30% to 40%, bladder, 40%; renal cell cancer, 20% to 25%; and melanoma, 14% to 45%.

In the United States, denosumab is also indicated for giant cell tumor of bone, which, globally, accounts for 4% to 5% of primary bone tumors. In China, however, giant cell tumor accounts for 20% of primary bone tumors.

China’s National Medical Products Administration (NMPA) has accepted Henlius Biotech’s new drug application for its denosumab biosimilar, hlx14.
 

Henlius' Denosumab Biosimilar Application Is Accepted by NMPA

Roughly 8 months after Ruxience (rituximab) was approved by the FDA, Pfizer has announced that the biosimilar has been approved by the European Commission (EC) for the same indications. A European market launch is anticipated in “coming months,” the company 

The biosimilar is a monoclonal antibody (mAb) accepted by the EC for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).

In the United States last year, Ruxience was approved for all of the above indications except RA and PV.

The EC approval is based on a data package that demonstrated biosimilarity of RUXIENCE to the reference product, MabThera. The originator rituximab is sold as Rituxan in the United States.

This included results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics, and pharmacodynamics of Ruxience and found no clinically meaningful differences in safety or efficacy compared with the reference product in patients with CD20-positive, low-tumor-burden follicular lymphoma, Pfizer said.

“Biosimilars like RUXIENCE exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs,” said Masum Hossain, regional president, Oncology International Developed Markets at Pfizer.

“Building on our ongoing commitment to bring biosimilars to market, we look forward to making RUXIENCE available to patients in the EU in the coming months,” he said.

RUXIENCE targets a protein called CD20, which is present on the surface of B lymphocytes, also known as B cells. When it attaches to CD20, rituximab helps destroy these B cells.

At about the same time that it launched Ruxience on the US market, Pfizer also introduced 2 other products: Trazimera, a trastuzumab biosimilar; and Zirabev, a biosimilar to bevacizumab.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Friday recommended marketing authorization in January 2020.

According to the CHMP, Ruxience will be available as 100- and 500-mg concentrates for solution for infusion. Rituximab is used in conditions such as NHL, CLL, RA, GPA, MPA, and PV, according to a press release.

Following close on the heels of its US approval for Ruxience (rituximab), Pfizer has gained the European Commission nod and aims to launch in coming months.

Pfizer Gains European Commission Approval for Rituximab Biosimilar

The Russian company Biocad received marketing approval for 2 biosimilars in Bosnia and Herzegovina, a country on the Balkan Peninsula in Southeastern Europe, and aims to expand sales further into Europe.    

The registration for the biosimilars of rituximab and trastuzumab, Acellbia and 

, respectively, was granted by The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. Market launch, largely through individual contracts with state and private cancer centers, will start this year.

Biocad will produce the agents and distribution will be managed by ICM, according to a 

. ICM estimated the market for rituximab and trastuzumab Bosnia and Herzegovina at around $12.7 million.

“The sale of these medicines on the market of Bosnia and Herzegovina will enable significant savings in the Federal Health Insurance Fund [FHIF] and at the same time enable patients to receive more effective treatment,” according to Nicola Rosi&#269;, chief executive officer of ICM, a distribution company based in Bosnia and Herzegovina.

“By analyzing international markets for launching drugs, we see that our products are in demand,” said Dmitry Morozov, chief executive officer of Biocad. “Therefore, in parallel, we conduct registration processes in different countries of Europe. For example, after successful registration in Bosnia and Herzegovina, we are planning to gain access to the Serbian market.”

Biocad’s Herticad has been approved for use in Russia and has been available since 2016.

The healthcare system in Bosnia and Herzegovina is 

 to be troubled by underfunding and a shortage of trained personnel caused in part by wartime exodus. The FHIF supervises the management of mandatory health insurance funds collected by the state healthcare system’s 10 health departments.

Russian company Biocad gains distribution rights for its rituximab and trastuzumab biosimilars in Bosnia and Herzegovina.

Biocad and ICM Gain Biosimilar Foothold in Southeastern Europe

Nepexto, an etanercept biosimilar, has gained a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending use of the product.

Nepexto has received a positive opinion for all indications of the reference product (Enbrel), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and nonradiographic axial spondyloarthritis), plaque psoriasis, and pediatric plaque psoriasis, according to Mylan NV and Lupin Limited, which have partnered in the development of the biosimilar.

“This milestone brings us 1 step closer to bringing an affordable biosimilar to etanercept to the European market through our partner Mylan,” said Vinita Gupta, chief executive officer of Lupin, in a 

. The companies began collaborating in 2018 to bring an etanercept biosimilar to the European market.

Enbrel, marketed by Amgen and Wyeth Pharmaceuticals, had sales of roughly $9.6 billion globally in 2019, according to IQVIA. In the United S, the comparable revenue figure was 

The EMU committee opinion was based on a bioequivalence assessment that included preclinical and clinical studies. In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to the reference product in terms of efficacy, safety, and immunogenicity, the statement said.

There are 2 approved etanercept biosimilars in the US: Samsung Bioepis’ Eticovo and Sandoz’ Erelzi. However, neither has launched. Erelzi received FDA approval in 2016 and has been delayed by litigation. Eticovo was approved in 2019, and no launch date has been announced.

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

Etanercept Biosimilar Is Recommended for Use in European Union

 on their plans for bringing an adalimumab biosimilar to market in the United States, Europe, and selected Southeast Asia markets.

Alvotech Hf, of Reykjavik, Iceland, and DKSH, of Zurich, Switzerland, said they have entered into an exclusive license partnership for the commercialization of AVT02, a biosimilar to AbbVie’s Humira, a leading drug for the treatment of several autoimmune diseases, including rheumatoid arthritis, ankylosing spondlytis, plaque psoriasis, psoriatic arthritis, ulcerative colitis, and Chron disease. Humira had worldwide sales of $18.4 billion in 2017.

DKSH, although based in Zurich, specializes in helping companies market their products and services in the Asia-Pacific region, where the DKSH is active in 36 emerging countries.

“Through the partnership, Alvotech Hf gains access to DKHS’s strong commercial network, which will ultimately benefit patients who will get better access to high-quality biosimilar medicines,” Mark Levick, chief executive officer of Alvotech Hf, said.

The companies said an approval application for AVTO2 will be filed with the European Medicines Agency and the FDA in the second half of 2020.

There are 5 adalimumab biosimilars to Humira that have been approved in the US market, none of which is expected to be commercialized until 2023, owing to deals negotiated as a result of AbbVie’s exclusivity rights.

Several adalimumab biosimilars launched in Europe for the first time in 2018, following Humira patent expirations in 2017. Stronger patent filings in the US have been attributed to the earlier EU launches.

Dozens of companies around the world have adalimumab biosimilars in development, including in India, Japan, Singapore, China, and the Republic of Korea.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.
 

Alvotech Hf and DKSH Announce Plans to Bring an Adalimumab Biosimilar to Market

What were the top-five most significant legal developments in the world of biosimilars in 2016? 

Here is the scoop according to and reported by 

 the 21st Century Cures Act.  Among other things, the Act modifies the standards and review processes for FDA evaluation of applications to market new drugs, and 

 for drug companies to develop treatments for rare diseases.

 that the BPCIA’s 180-day notice of commercial marketing cannot begin until after a biosimilar applicant has received FDA licensure, and that the notice of commercial marketing provision is mandatory and enforceable by injunction, even for an applicant that has engaged in the patent dance.  The 

.  In the first decision addressing the new PTAB proceedings established by the America Invents Act, the Court held that the Patent Trial and Appeal Board’s (PTAB) determination on whether to institute an inter partes review is not appealable in most cases and that the PTAB’s broadest reasonable interpretation standard in claim construction is proper.

2) States continue to pass biosimilar substitution laws. As we reported 

, several states passed laws in 2016 that allow pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA.

 worked its way toward the Supreme Court.  If the Supreme Court decides to hear the case, it could clarify important provisions of the BPCIA related to resolving patent disputes regarding biosimilar products.

 a) that the disclosure procedures set forth in subsection (l)(2)(A) of the BPCIA (the “patent dance”) are not mandatory and a biosimilar applicant can choose between either disclosing application and manufacturing information or not disclosing such information and instead facing an immediate infringement action from the reference product sponsor; and (b) that a notice of commercial marketing pursuant to subsection (l)(9)(A) of the BPCIA can be given only after FDA approval of the biosimilar product, effectively extending the reference drug’s exclusivity by 180 days.  In February 2016, Sandoz 

filed a petition for a writ of certiorari

, asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision.  In March, 

 and also filed a conditional cross-petition for certiorari, challenging the Federal Circuit’s ruling that the patent dance is optional. Several entities filed amicus briefs supporting Sandoz’s petition. 

 recommending that the Supreme Court grant both Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret the BPCIA, and also siding with Sandoz on the merits of the questions. The Solicitor General’s recommendation that the Court grant cert is a very strong indicator that the Court will grant the petition and cross-petition.