Valerie DeBenedette is a medical news writer in Putnam County, N.Y.

Valerie DeBenedette

 on how drug companies can create “interchangeable” biologics, AKA biosimilars. The final guidance on interchangeability is intended to provide clarity for developers who want to demonstrate that their biological product meets the statutory interchangeability standard set down in the Public Health Service Act (PHS Act), which means that it can be substituted for the brand version of the drug.

“Biologics provide important treatment options for patients with serious diseases like cancer, rheumatoid arthritis, diabetes and multiple sclerosis,” says Norman E. Sharpless, MD, the FDA’s acting commissioner, in a statement.

The FDA has been working to implement a 

 that includes several efforts to encourage innovation and competition among biologics and to develop lower-cost biosimilars. The guidance allows manufacturers to know what steps they need to take to show interchangeability.

A Big Storm Brewing for American Specialty Pharmacies and Patients

“This pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, by increasing access to life-saving medications and potentially lowering health care costs through competition,” Sharpless says.

The FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement meets the applicable standard, that it is biosimilar to the brand (the reference product) and can be expected to produce the same clinical result as the reference product in patients.

Congress created an approval pathway for biological products In the Biologics Price Competition and Innovation Act of 2009 (BPCI Act. So far, only 19 biosimilar products have been approved by the FDA, many of which have not reached market.

Articles

Biosimilar guidance provides “clarity” for drug developers.

FDA Finalizes Guidance on Interchangeability for Biologics

 Evenity (romosozumab-aqqg, Amgen) as a treatment for osteoporosis in postmenopausal women who are at high risk for bone fractures. This includes women with a history of osteoporotic fracture, who have several risk factors for fracture, or who have failed on or are intolerant of other treatments for osteoporosis.

The drug is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation. The dosage for Evenity is two injections, one after the other, once a month, administered by a healthcare professional. However, the bone-forming effects wane after 12 doses, and labeling states that no more than 12 doses should be used. If osteoporosis therapy is still needed after 12 doses, the patient should be started on an osteoporosis treatment that reduces bone breakdown.

More than 10 million people in the United States have osteoporosis, and it is most common in postmenopausal women. Evenity is a new option for older women with osteoporosis,” says Hylton V. Joffe, MD, director of the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products. “But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it’s important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year.”

The labeling for Evenity contains a boxed warning stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year. Healthcare professionals should also consider whether the benefits of Evenity outweigh its risks in those with other risk factors for heart disease, and should discontinue it in any patient who experiences a heart attack or stroke during treatment. Common side effects included joint pain and headache. Injection site reactions were also observed.

The safety and efficacy of Evenity were demonstrated in two clinical trials that enrolled more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with Evenity lowered the risk of a new vertebral fracture by 73% compared to placebo. This benefit was maintained over the second year of the trial when Evenity was followed by one year of denosumab compared to placebo followed by denosumab. In the second trial, one year of treatment with Evenity followed by one year of alendronate reduced the risk of a new vertebral fracture by 50% compared to two years of alendronate alone. Evenity followed by alendronate also reduced the risk of fractures in other bones compared to alendronate alone. Evenity increased the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial. 

Evenity (romosozumab-aqqg) has been approved to treat postmenopausal women at high risk of bone fractures.

FDA Approves Evenity for Osteoporosis

The unexpected resignation of Scott Gottlieb, MD, as commissioner of the FDA startled the healthcare industry. He will be stepping down as commissioner of the FDA at the end of March.

During a time of political divisiveness, Gottlieb won bipartisan praise for his public health initiatives. His tenure has been marked by his aggressive work to reduce tobacco use by teens and a large increase in the approvals of generic drugs. He also took on issues like drug pricing. Unusual for the head of the FDA, he was active in nutritional matters, such as keeping Obama-era requirements that restaurant menus post calorie counts and that food labels include information on added sugar.

In the two years since Gottlieb took the job, the FDA approved a record number of generic drugs, new drugs, and medical devices. He spoke publicly about high costs of prescription drugs, a subject most FDA heads shy away from. In 2017, the FDA released the Drug Competition Action Plan, which is intended to lower barriers for creating and marketing generic drugs. Gottlieb spoke out against drug makers who use tactics intended to delay development of generic versions of medications, such as refusing to release drug samples needed to develop generics. The FDA even started a public list of complaints against companies that used these tactics.

The quickening pace of approvals for biosimilar drugs is directly attributable to Gottieb, says Christine Simmon, JD, executive director of the Biosimilars Counsil of the Association for Accessible Medicines. "He has really made biosimilars a focal point of the agency's efforts." she tells 

"Just by talking about them in addition to approving them, I think has as put them front and center

in the minds of policy makers looking for solutions to high drug prices."

“APhA wishes Commissioner Gottlieb well in his next endeavor,” says CEO Thomas E. Menighan, BSPharm, MBA, FAPhA, in a statement to 

. Looking forward to whoever the next commissioner will be, Menighan adds: “APhA is committed to continuing its work with the FDA to address issues to secure the quality and safety of our nation’s medication distribution and use systems, access to affordable pharmaceuticals and technology, and optimization of pharmacists’ knowledge and skills to improve our nation’s public health.”

The American Cancer Society praised Gottlieb’s work against vaping and teenaged use of tobacco, according to the 

. “Gottlieb has taken historic steps to take on this epidemic in a new way, including such proposals as reducing nicotine in cigarettes to nonaddictive levels and now pursuing a potential ban on menthol in cigarettes, so it is critical that whoever succeeds him picks up that mantel and treats it with equal priority that he has given it,” says Cliff Douglas, vice president of tobacco control at the society.

Gottlieb says that he is quitting because he was tired of splitting time between Washington and his family home in Connecticut, where he and his wife are raising their three children. He had previously worked at the FDA as deputy commissioner for Medical and Scientific Affairs. He had also been a venture capitalist, and served as a board member and consultant for pharmaceutical companies.

Scott Gottlieb’s tenure at the FDA was marked by hundreds of generic approvals and aggressive moves against the tobacco industry and vaping.

Gottlieb Resigns from FDA, Focused on Generics and e-Cigarettes

Whether you call it convenience packaging, compliance packaging, or adherence packaging, community pharmacies should consider offering this service to their patients, and marketing it to other healthcare providers, patients’ caregivers, and to health facilities. A panel discussion on convenience packaging, held October 7 at the NCPA 2018 Annual Convention in Boston, looked at three aspects of the subject: the common types of packaging, marketing the service, and best practices.

Convenience packaging prepacks a patient’s medications into blister packs or packets, portioned out and marked with the time of day they should be taken. It can be a profitable opportunity because it allows the pharmacy to make a complex regimen of medications easier for patients and caregivers, presenter Steve MacNeill, RPh, tells Drug Topics in an interview before the meeting.  MacNeill is owner of Winchester Pharmacy in Winchester, MA.

Packaging systems for medications include hot seal, cold seal, robotic technology, daily dose packs, and multidose bubbles, said presenter Carlie Traylor, PharmD

associate director of strategic initiatives. Systems are available that seal the pills and capsules into card-backed blister packs, either as daily dose packs or monthly packs, with some allowing for multiple pills in each blister. Other systems place medications into small packets that are labeled and sealed, with some creating a continuous strip of packets.

Staff training and equipment required varies with the type of system, ranging from smaller systems taking up part of a counter to some larger robotic systems taking up floor and office space. Robotic systems might be best suited for pharmacies that have already been doing compliance packaging on a smaller scale, she said.

MacNeill agreed, noting that there are many systems out there and no one system is right for every pharmacy. He also stressed that a community pharmacy has to start slowly with convenience or adherence packaging, noting that pharmacists should consider:

The potential impact on their daily work flow,

The appearance of the software interface,

Benjamin McNabb, PharmD, owner of Love Oak Pharmacy in Eastland, TX, noted that his patients who get prepacked medications take an average of 11 prescriptions a month and are often willing to pay the nonpreferred pharmacy copays at his pharmacy because of the extra value they are getting. As patients with complex conditions, they often need other products and services from the pharmacy, he adds. 

MacNeill said the target market for compliance or adherence packaging is patients who take multiple medications per day, who have had repeat hospital or emergency department visits, who seem to have frequent early or late refills, and use home healthcare or have family taking care of their health needs.

Jeff Kirchner, RPh, CEO, Streu’s Pharmacy Bay Natural, Green Bay, WI, noted that he provides convenience packaging for children because local schools have rules against kids having a whole bottle of medications with them.

The packaging service does not sell itself, McNabb noted. It has to be marketed to patients and the community at large with a compelling message. A 

 he created for his pharmacy’s blog ended up being used on a Texas television station after a Cowboys football game. Within days, the number of people asking for the service multiplied.

Kirchner recommends creating a brochure about compliance packaging, along with samples of the packets or blister cards. His pharmacy offers single-dose, multidose, weekly, and monthly compliance packs.

There is a time element that has to be built into this kind of packaging, Kirchner added. You have to synch all medications, bill seven to 10 days before the start date of the next pack, check for any needed refills 20 to 30 days before the next pack, and fill meds five to seven days ahead, he said. Then home delivery should be done three to five days before the patient needs to start that pack.

Compliance packaging, also called convenience packaging, is a good idea for both patients on many medications and for pharmacies. Here’s how to do it.